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Stryker

via Workday

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Regulatory Compliance Specialist (Remote)

Anywhere
full-time
Posted 8/8/2025
Direct Apply
Key Skills:
Post-market regulatory activities
Product field actions
Complaint handling
Adverse event reporting
FDA and international medical device regulations
Cross-functional collaboration
Analytical and problem-solving skills

Compensation

Salary Range

$69K - 140K a year

Responsibilities

Support post-market regulatory activities, analyze data for trends, assist with quality improvements, communicate with customers and regulatory agencies, and participate in audits and complaint handling.

Requirements

Bachelor’s degree in Science or related field with 0-2 years experience in regulated manufacturing, strong analytical skills, and familiarity with FDA and international medical device regulations preferred.

Full Description

Work Flexibility: Remote Stryker is seeing a Regulatory Compliance Specialist for our Endoscopy division. This is a remote role located anywhere within the US. What you will do As the Regulatory Compliance Specialist, you will support post-market regulatory activities that ensure the safety and effectiveness of our products in the field. Support assessments and documentation for product field actions and commercial holds Review and analyze post-market data to identify trends and potential issues Collaborate with cross-functional teams to develop and implement quality improvements Assist in preparing reports and summaries for internal and external stakeholders Communicate directly with customers and regulatory agencies regarding reported complaints and resolutions Participate in complaint handling and adverse event reporting processes Contribute to internal audits and regulatory inspections Use sound judgment to identify areas for improvement and support corrective actions What you need Required Bachelor’s degree in Science, Engineering, or related field 0–2 years of experience in a regulated manufacturing environment Strong analytical and problem-solving skills Ability to manage multiple tasks and meet deadlines Preferred Familiarity with post-market regulatory activities, including product field actions and product holds Knowledge of FDA and international medical device regulations (e.g., 21 CFR Part 803, 21 CFR Part 820, ISO 13485) Experience with MDR/MIR reporting Exposure to cross-functional collaboration in a quality or regulatory setting $69,100 - $139,600 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

This job posting was last updated on 8/8/2025

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