Regulatory Compliance Specialist (Remote)

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.