BIOTRONIK

Compensation

Full Description

Compliance Monitoring and Program Manager BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees. The Ethics and Compliance Department of BIOTRONIK, Inc. is a dynamic team that functions cohesively to ensure that BIOTRONIK conforms to its values of ethical business practices. The Compliance Monitoring and Program Manager will enhance and elevate various program elements of the existing BIOTRONIK, Inc. Compliance Program. The Compliance Monitoring and Program Manager will operate in a multi-disciplinary and interdepartmental capacity, as well as be a key BIOTRONIK, Inc. compliance contact for industry associations and various governmental agencies with the ability to significantly affect company change, enhance controls, and elevate employees’ understanding of compliance. The Compliance Monitoring and Program Manager is a key position in the US Compliance Department and requires an ability to work within tight timelines and periodic extensive travel. A quick learning curve will be needed for this role as the position will be fast paced and impactful. Candidates who love challenging and dynamic roles are best suited for this position. Your Responsibilities • Oversee and execute BIOTRONIK, Inc.’s Compliance Monitoring Program including the planning, preparation, execution and review of all live monitoring and document review activities, as well as managing the compliance monitoring support team. • Oversee and execute the on-going back office monitoring efforts. • Assist in partnership with the VP, Compliance & Risk Management and Sr. Compliance Manager the annual Risk Assessment efforts for BIOTRONIK, Inc. • Provide consistent and thoughtful compliance guidance to applicable functional teams and sales employees. • Lead remediation of issues identified in monitoring and investigations including identifying compliance gaps and root cause and developing and implementing corrective action. • Design in collaboration with Compliance Management and execute with applicable compliance team support quarterly Monitoring Sub-Committee meetings and Incidence of Non-Compliance Meetings. • Manage direct reports and mentor all levels of staff. • Serve as a key document collector for 3rd party and internal auditors as well as a point of contact for questions. • Update compliance policies and procedures as necessary. • On occasion, last minute travel may arise depending on time sensitive compliance matters. • Review potential conflicts of interest and incidents of non-compliance and conduct investigations as necessary with oversight from VP, Compliance & Risk Management. • Provide advice and assist Transparency team in annual filing as requested. • Act as Compliance reviewer for promotional and educational materials as needed. • Review grant requests as a member of the Financial Grant Committee. • Deliver live training to all levels of BIOTRONIK personnel and assist with launch of online training courses. • Assist with screening processes and help with applicable remediation. • Act as Compliance reviewer for Needs Assessments and HCP engagement requests. • Drive the development, implementation, and continuous improvement of an effective Ethics & Compliance Program. • Perform other duties as assigned. • Be responsive when sales and functional needs arise. Your Profile • Bachelor’s Degree is required. Relevant fields are preferred but will consider all majors. At least 4-6 years of progressive Healthcare Compliance experience with at least 2 years being in a leadership position. • Ability to work in a very fast paced medical device sector. • Ability to modify work priorities as issues arise. • Ability to travel. • Ability to navigate in a cross-functional environment. • Experience with governmental reporting. • Strong compliance monitoring and/or audit experience. • Strong managerial and leadership skills. • Knowledge and understanding of applicable regulations, recent enforcement actions and trends (e.g. Corporate Integrity Agreements in the life science industry), and ethics & compliance best practices including: • AdvaMed Code of Ethics, • Anti-Kickback Statute • False Claims Act • Physician Payments Sunshine Act • Experience conducting investigations, determining root cause, and driving corrective actions. • Strong analytical and decision-making skills and confidence providing guidance to business stakeholders. • Ability to apply project management and change management techniques to internal projects. • Excellent communication skills, including the ability to communicate with high-level management, to influence others without authority when necessary, and to conduct contentious and critical investigative interviews. • Positive attitude and willingness to work as part of a team and mentor other team members. • Ability to work independently. • Demonstrated ability to lead compliance projects and meet ambitious project milestones and objectives. • Strong organizational skills and attention to detail. • Proficient PC application skills, including knowledge of MS Excel, email systems, etc. Experience with enterprise systems (e.g. SAP, Concur, Salesforce) or business intelligence/data analysis tools is a plus. • Strong integrity/ethics and commitment to excellence. Preferred Education and Experience • Experience working in the medical device industry. • Significant experience leading cross-functional initiatives. • Experience working with or on governmental based projects. • Advanced degree (e.g. Master’s degree in health-related discipline) and/or certification (e.g. CCEP). Supervisory Responsibilities Lead functional work teams as needed. This position will have one to two direct reports. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers. Physical Demands This is a largely sedentary role. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to talk and hear. All reasonable accommodations will be made. Position Type/Expected Hours of Work This is a full-time position. Standard days of work are Monday through Friday. Hours of work may vary depending on time zone supported. Occasional evening and weekend work may be required as job duties demand. Travel Travel is required, estimated at twenty percent (20%) per year. Location This position will be a remote based position in the United States. Are you interested? Please apply online through our application management system! We are looking forward to welcoming you. Location: Remote out of Lake Oswego, Oregon | Working hours: Full-time | Type of contract: Undefined Job ID: 62006 | BIOTRONIK Inc. | USA We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.