Getinge

The Customs & Import-Export Specialist will manage import customs clearance processes and ensure the accurate and timely submission of customs entries. This role involves handling high volume import/export documentation and coordinating with third-party logistics teams for order fulfillment. | Candidates must have a bachelor's degree in a related field and a minimum of 3 years of experience in the freight forwarding industry. Experience with U.S. Customs and Partner Governmental Agencies is also required. | With a passion for life   Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it.     Job Overview  The position will manage import customs clearance processes to execute the daily movement of freight and parcel shipments to our customers and internal network. The position operates in a fast-paced environment and works closely with our third party logistics teams for order fulfillment. The position works with minimal supervision and is responsible for the accurate and timely submission of customs entries for clearance through U.S. Customs and Border Protection and Partner Government Agencies (PGA). It handles high volume import/export documentation while maintaining accuracy and efficiency standards. It is required to prepare import/export documentation (Customs entry package, SLI, export certificates, export declaration and carrier air waybills) between customers, vendors, forwarders, brokers, and other government agencies. This position will be remote, however requires in-person training in New Jersey for the first 2-4+ weeks.    Job Responsibilities and Essential Duties  Process Customs entries within a 5 day window of vessel arrival, ensure Customs release and update file notes. Minimum file count 75 entries monthly. This includes following up with U.S. Customs, FDA and other PGAs to ensure releases are posted timely.   Process timely ISF no later than 24 hours before vessel departure.  Able to review documents and assess accuracy, verifying country of origin/export, IOR, terms of sale and value to ensure that compliance with all applicable laws and regulations prior to entry submission to U.S. Customs and Partner Governmental Agencies (PGAs) are achieved for import/export shipments.  Coordinate exams/sampling, communicate holds, monitor timeframes when FDA detained and ensure FDA refusals are properly handled timely.   Responsible for day-to-day coordination, execution, and tracking of import/export shipments shipped from our Distribution Center and manufacturing plants.  Process international export outbound orders timely for entities to maintain KPI’s & customer expectations, and prioritize, arrange booking and schedule pickups for export freight shipments.  Process Dangerous Goods freight and parcel orders according to Department of Transport (DOT) & International Air Transport Association (IATA) regulations.  Review and properly rate commercial invoices to verify the accuracy of classification and/or valuation.   Follow Automated Commercial Environment (ACE) audit procedures and ensure all import auditing inquiries are handled in a timely manner (prior to duty payment).  Calculate duties and taxes to ensure the correct fees are paid to US Customs.   Create internal Automated Clearing House (ACH) report and send to Account Payable for processing against General Leger accounts.  Administrative responsibilities include:  Maintain all customs documentation in conformance with U.S. Customs record retention requirements, and manage documents by maintaining all import and export documentation to designated SharePoint folders.   Handle internal billing and preparation of weekly reporting for import/export shipments.   Follow up on all import/export parcel exceptions and clearance delays until delivery is confirmed.  Communicate with cross functioning teams for any import/export requirements or exceptions found in freight documents, ship instructions or physical cargo receipt, and provide ongoing support for internal operations with overseas factories and Sales and Service Units (SSU).  Post entry summary corrections or updates and applies for refunds when applicable.    Minimum Requirements  Bachelor’s degree in International Business, Supply Chain Management or related field, or equivalent combination of education and relevant experience  Minimum of 3 years of experience in the freight forwarding industry  Minimum of 3 years’ brokerage experience working as an entry writer  Minimum of 2 years’ experience with USHTS, Schedule B and ECCN classifications  Minimum of 2 years’ experience with Partner Governmental Agencies – CBP, FDA, EPA, TSCA  Knowledge of general freight forwarding terms and standards  Experience with Dangerous Goods & Hazmat shipment requirements   Certification in Certified Export Specialist (CES), Certified Customs Specialist (CCS), or Certified Import Specialist (CIS) strongly preferred  SAP and GTS system experience preferred    Required Knowledge, Skills and Abilities  Ability to prioritize and multi-task in a fast-paced environment with strong time management skills and ability to be consistent in follow-up and follow-through  Understands and responds to situations that require a sense of urgency  Analytical, problem solving and decision-making skills  Strong organizational skills and attention to detail  Strong customer service skills and able to build relationships with cross functioning teams  Excellent oral, written communication and interpersonal skills  Proficient in Microsoft Office programs    Supervision/Management Of Others:  The position does not supervise/manage other employees.    Internal and External Contacts/Relationships  All levels of employees  External customers and governmental agencies, forwarders, brokers and vendors.     Environmental/Safety/Physical Work Conditions  Ensures environmental consciousness and safe practices are exhibited in decisions  Use of computer and telephone equipment and other related office accessories/devices to complete assignments  May work extended hours during peak business cycles  The salary range for this position is between $70,000-90,000 per year depending on experience and location with an 8% bonus.  #LI-MV1   About us  With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.     Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Tuition Reimbursement   Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Conduct global internal audits to ensure compliance with regulatory requirements and maintain audit documentation. | Bachelor's degree or equivalent, 3+ years quality system audit experience, knowledge of medical device regulations, and evidence of training to relevant quality standards. | With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Corporate Quality Internal Auditor will perform Global Internal Audits to improve compliance throughout Getinge sites, providing early warning of noncompliance and other regulatory requirements. They will be responsible for conducting audits, as required, and completing the associated documentation in a timely manner. This is a fully remote position. Job Responsibilities And Essential Duties • Ensures that Getinge Corporate Internal Audits are completed in compliance with regulatory requirements and documented procedures • Able to coordinate, collaborate and manage audits as lead auditor at various global Getinge locations • Maintain Documentation for Getinge Corporate Internal Audits in Associated databases • Follow up with audited sites for audit nonconformance completion • Ability to track and prepare trend reports on audits and non-conformances • Able to manage conflict resolution that may arise during audit completions Minimum Requirements • Bachelor’s Degree (BA/BS) or equivalent, preferably in a life science or related discipline, or an equivalent combination of education and experience • Minimum 3 years’ experience in Quality System Audit • Proven experience in completing and maintaining audit documentation • Proficient using MS Office applications Required Knowledge, Skills And Abilities • Working knowledge of all elements of a Quality System, in particular Internal Audit, Corrective, and Preventive Action Subsystems. • Education and Experience to understand and comply with U.S. and Worldwide medical device regulations. • Evidence of training to QSmR, ISO 13485:2016, EU MDR, MDSAP and ISO 9001:2015 • Valid passport and ability to travel internationally Internal and External Contacts/Relationships • Interacts with all levels of Global Getinge teams • External contacts are limited Environmental/Safety/Physical Work Conditions • Ensures environmental consciousness and safe practices are exhibited in decisions • Use of computer and telephone equipment and other related office accessories/devices to complete assignments • May work alternate or extended hours while performing audits • Domestic and International Travel will be required of about 35% The base salary for this position is a minimum of $90,000 and a maximum of $110,000 plus an annual bonus of 8% About Us  With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.   Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Lead global post-market surveillance activities including complaint trending, vigilance reporting, regulatory compliance, and cross-functional collaboration for Class II/III medical devices. | Bachelor's degree plus minimum 5 years in medical device quality assurance or regulatory affairs with expertise in PMS, complaint handling, regulatory audits, and relevant certifications preferred. | **Job Overview and Responsibilities** The Senior Quality Engineer, Post Market Surveillance, leads and executes global post-market surveillance (PMS) and post-market clinical follow-up (PMCF) activities for Class II/III medical devices across the product lifecycle. This role owns the processes for complaint trending, signal detection, nonconformance escalation, and vigilance reporting to ensure regulatory compliance and continuous improvement. The incumbent acts as a Subject Matter Expert (SME) for PMS, interfacing with regulatory authorities and leading regulatory and notified body audits. They contribute to strategic quality initiatives by developing Periodic Safety Update Reports (PSURs), supporting Clinical Evaluation Reports (CERs), and driving risk-benefit assessments, field actions, and CAPA resolution. This role requires strong cross-functional collaboration and the ability to translate complex quality data into meaningful regulatory, clinical, and product performance insights. The position supports both the Cardiac Assist (CA) and Cardiac Surgery (CS). - Lead global post-market surveillance activities including complaint handling, vigilance reporting, and trend analysis in compliance with FDA 21 CFR 803, EU MDR, ISO 13485, and other applicable regulations. - Perform proactive analysis of complaint, nonconformance, and manufacturing data to identify emerging quality signals; escalate findings and initiate CAPAs or risk mitigations as appropriate. - Own the development and submission of Periodic Safety Update Reports (PSURs) and Post-Market Surveillance Reports (PMSRs), consolidating product safety, complaint, and performance data. - Provide strategic inputs and post-market data for Clinical Evaluation Reports (CERs), including benefit-risk updates, complaint summaries, and safety conclusions. - Lead cross-functional investigations for post-market safety signals, adverse events, and field performance issues using structured root cause analysis tools (e.g., 5 Whys, Fishbone, FTA). - Support and lead Health Hazard Evaluations (HHEs), field action decision-making, and recall execution activities. - Monitor and interpret manufacturing-related triggers and nonconformance trends to anticipate field risk; integrate findings into PMS documentation and quality improvement plans. - Ensure maintenance and accuracy of complaint and nonconformance databases; align data categorization and risk logic with Risk Management Files (RMF) per ISO 14971. - Represent PMS as a Subject Matter Expert during internal and external audits (FDA, Notified Body, MDSAP), including preparation and defense of complaint and surveillance data. - Lead CAPA activities arising from post-market insights, ensuring effective root cause analysis, corrective action implementation, and timely closure. - Collaborate with cross-functional teams (Regulatory, Clinical, R&D, Manufacturing, Medical Affairs, and Commercial) to align on product safety and surveillance strategies. - Identify and drive continuous improvement initiatives in PMS processes, procedures, and system tools; contribute to updates of SOPs, templates, and quality system documentation. - Support quality input into design changes, supplier quality assessments, and validations based on post-market feedback. - Work special projects as assigned. • *Qualifications and Requirements** - Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline is required. - Minimum 5 years of experience in Quality Assurance, Post-Market Surveillance, or Regulatory Affairs within the medical device industry. - Demonstrated experience leading complaint handling, vigilance reporting, signal detection, and PMS documentation for Class II/III medical devices. - Prior experienced preferred in participation of FDA inspections, Notified Body audits, or MDSAP assessments as a Quality or PMS subject matter expert. - Strong working knowledge of U.S. and international medical device regulations, including FDA 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR (Annex III), and MEDDEV 2.12/1. - Proven ability to prepare and lead development of PSURs, PMSRs, and inputs to CERs with cross-functional collaboration. - Working knowledge of databases and templates used in PMS documentation. - Strong understanding of complaint handling, signal detection, risk management, and field corrective action processes. - Familiarity in structured problem-solving tools (e.g., 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis, A3) and CAPA systems. - Proficiency in complaint trending and statistical analysis using Excel, Minitab, or other quality tools. - Ability to generate visual reports/dashboards and interpret data to support decision-making. - Ability to collaborate cross-functionally with Regulatory, Clinical, Manufacturing, and Medical Affairs teams. - Strong verbal and written communication skills, including preparation of regulatory submissions and audit responses. - Ability to influence and Collaborate with cross-functional (Regulatory, Clinical, Manufacturing, and Medical Affairs) teams and effectively communicate technical content to regulatory authorities and internal leadership. - Ability to mentor or coach junior engineers or team members in PMS activities is a plus. - Preferred to be Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC). - Deep knowledge of global post-market regulatory frameworks, including FDA 21 CFR Part 803, ISO 13485, ISO 14971, and EU MDR Annex III for PMS/PMCF. - Familiarity with international vigilance reporting standards (e.g., FDA MDR, EU MIR, Health Canada, and other global authority expectations). - Proven ability to lead end-to-end PMS processes, including signal detection, trend analysis, risk escalation, and cross-functional risk-benefit reviews. - Experience generating and owning regulatory deliverables such as PSURs, PMSRs, HHE justifications, and contributions to Clinical Evaluation Reports (CERs). - Proficient in complaint handling, product investigations, signal detection, and trend analysis. - Skilled in applying risk management principles throughout the product lifecycle, including updating Risk Management Files (RMFs) based on post-market feedback. - Strong analytical skills with the ability to interpret large sets of complaint and quality data to identify trends and generate actionable insights. - Experience with tools such as Excel, Minitab, Tableau, or similar for visualizing and communicating trends. - Hands-on experience with electronic QMS and complaint handling systems (e.g., TrackWise, Windchill). - Excellent verbal and written communication skills, especially for preparing regulatory submissions and audit responses. - Demonstrated ability to work cross-functionally with Regulatory Affairs, Clinical, R&D, Manufacturing, and Commercial teams. - Confidence in representing PMS processes and data during internal audits, FDA inspections, and Notified Body reviews. - Ability to translate complex post-market data into clear, concise justifications and regulatory narratives. - Proactive, detail-oriented, and committed to identifying system gaps and driving improvements in PMS processes and documentation. - Regular interaction with internal stakeholders across all levels and functions, including R&D, Regulatory Affairs, Operations, Medical Affairs, and Supplier Quality. - May engage externally with auditors, and regulatory authorities as a representative of the Quality function. • *Pay and Benefits** $100,000 - $120,000

Execute marketing operations including go-to-market plans, content calendar coordination, digital asset creation, campaign management, and stakeholder collaboration. | Bachelor’s degree or equivalent experience with 1-2 years marketing experience, proficiency in digital marketing tools, strong communication and organizational skills. | With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Marketing Specialist – Commercial strategy & Communications will support Getinge’s growth within the Surgical Workflows, Infection Control, and Digital Health sectors. The position is hands-on in all aspects of marketing operations for assigned product areas. Key responsibilities include collaboration with Product Management, Creative, Commercial Operations, and Global Marketing teams to execute strategic marketing initiatives that enhance the visibility and reputation of Getinge’s portfolio among health care providers, internal stakeholders, and customers. Main assignments include work in digital platforms, content development, and coordinated campaign management. Job Responsibilities and Essential Duties • Assist in the execution of go-to-market plans for new product introductions and strategic campaigns. • Coordinate omnichannel content calendars, asset tracking, and post-launch campaign reporting. • Support the creation and optimization of customer-facing messaging in alignment with product positioning. • Collaborate with internal and external stakeholders to create and deploy digital marketing assets (landing pages, emails, social media, paid ads, etc.). • Manage internal approval workflows using systems like Windchill. • Maintain and track updates to product pages, digital flyers, and sales enablement tools. • Serve as a key liaison between Product Management, creative agencies, and digital marketing teams to ensure timelines and brand consistency. • Coordinate with the Events and Trade Show teams to align campaign messaging across all touchpoints (booths, handouts, signage). • Help manage the social media calendar and content submissions to regional/global teams. • Track and manage project timelines, approvals, and launch deliverables. • Maintain accurate documentation of campaign components and update internal toolkits accordingly. • Compile competitive intelligence, market trends, and performance analytics to support strategic planning. Minimum Requirements • Bachelor’s degree in Marketing, Business, Communications, or a related field and/or equivalent combination of education and work experience. • 1-2 years of internship or professional experience in marketing, preferably in healthcare, life sciences, or B2B sectors. Required Knowledge, Skills and Abilities • Proficiency with Microsoft Office Suite (Excel, Powerpoint, Word). • Experience with project management platforms a plus (e.g. Monday.com, Trello, Asana) • Strong attention to detail, organizational skills, and ability to manage multiple priorities. • Excellent communication skills – verbal and written – and a collaborative mindset. • A self-starter with curiosity for healthcare technology and passion for meaningful impact. • Familiarity with digital marketing platforms (e.g. HubSpot, Salesforce Marketing Cloud, Google Analytics, Adobe Creative Suite). • Technical competence with marketing technology platforms including Showpad, Pardot, Google Ads, SEMRush, Mediahub. • Proficiency developing content for social media sites Annual salary of 78K to 95K (depending on experience) with 8% STIP #LI-YA2 #LI-Remote About us  With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.   Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits • 401k plan with company match • Paid Time Off • Wellness initiative & Health Assistance Resources • Life Insurance • Short and Long Term Disability Benefits • Health and Dependent Care Flexible Spending Accounts • Commuter Benefits • Parental and Caregiver Leave • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Lead and manage complex cross-functional projects with standardized project management methods, ensuring timely delivery and effective communication. | Minimum 4+ years project lead experience, PMP certification, proficiency with project management software, medical device industry knowledge preferred, and ability to manage technical meetings. | With a passion for life   Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it.     Healthmark, A Getinge company was founded in 1969 and employs over 300 people and is a growing company. We strive to provide customers with quality products and support services in a timely and effective manner.     Full Time/Fixed Term 12 months Monday - Friday   Job Overview:   The Project Manager will be responsible for the leadership of complex cross-functional projects. The individual will manage multiple product group remediation activities.  Additional project assignments may be assigned at the discretion of the supervisor and are based on business requirements. Key deliverables include the development of project timelines, project team assembly, managing the schedule for key deliverables, and maintaining effective communication throughout the project. This position is a fixed term for 12 months with potential for extension. The position is remote working Eastern Standard hours.      Job Responsibilities and Essential Duties Review current project landscape and define go forward execution strategy with stakeholder alignment. Develop and release all project-related deliverables, including project plan, schedule and report Manage a project with standardized methods and project models, including Waterfall or Agile Lead and support execution of technical and/or cross-functional project work Ensure the timely release of critical deliverables within the project Ensure all aspects of the project comply to internal procedures Understanding of group dynamics to influence team members Develop and present monthly status reports Effective communication with project stakeholders, local management, and global management Demonstrate leadership when facing uncertainty Instill confidence through leadership and actions Understand group dynamics and use this knowledge to lead the project Identify, support, and promote new concepts and initiatives related to Project Management within the organization as applicable and relevant to the success of the project. Communicate project status at defined intervals and meetings and escalate any concerns to the Supervisor and associated Management representatives.      Minimum Requirements BS in Business, Healthcare or equivalent experience Minimum of 4+ years in task or project lead role Domestic and/or international travel up to 20%     Required Knowledge, Skills and Abilities   PMP certification or equivalent required Experience with Microsoft Project and other project management software Experience in leading tasks/projects through a structured, phase-gate process Lead and manage technical meetings with cross-functional members Medical Device experience including thorough understanding of Medical Device Quality Management Systems (EU MDR 2017/745, ISO 13485, 21 CFR 820, ISO 14971) a plus Excellent interpersonal, verbal, and written communication skills; strong technical writing skills Well organized, detail oriented Task oriented and driven to complete assignments on schedule Must have the ability to effectively interface with both technical and non-technical personnel.  Ability to influence and direct personnel without direct supervision         Supervision/Management of Others:   N/A     Internal and External Contacts/Relationships   Frequent interaction with Supervisor/Manager and Senior Management, Product Management, Engineers, Quality Assurance, Regulatory Affairs, Clinical and Medical Affairs, and Marketing.   Work/mentor less experienced team members and/or peers on the project. Work with more experienced team members to understand products. Independent discussions/interaction with outside Customers, Vendors, and Consulting Firms   Physical Work Conditions   Use of computer and telephone equipment and other related office accessories/devices to complete assignments May work extended hours during peak business cycles Physical requirements such as lifting specific weights up to 25lbs on occasion Driving and Travel requirements   The salary range for this position is between $90,000-111,000 depending on experience and location #LI-MV1 About us   With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.   At Healthmark a Getinge company, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Tuition Reimbursement   Healthmark a Getinge company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.  The base salary for this position is a minimum of  $89,360.00 and a maximum of $111,700.00