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About the role
Key responsibilities & impact- Conduct post-market surveillance activities in compliance with applicable regulatory requirements.
- Document monthly Tracking and Trending reports.
- Write customer inquiry responses.
- Collaborate with cross‑functional teams to develop customer communications.
- Complete risk assessments/evaluations, and execute field action activities.
- Investigate complaints by gathering sufficient data from various sources.
- Write Medical Device Reports (MDRs) and timely communication to regulatory authorities.
- Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions.
Requirements
What you’ll need- Bachelors in related field or an equivalent combination of education and work experience.
- Minimum 6 years related work experience with a strong understanding of specified functional areas.
- Masters Degree preferred.
- Solid understanding and application of business concepts, procedures, and practices.
- Will perform this job in a quality system environment.
- Works on problems of diverse scopes where analysis of data requires evaluation of identifiable factors.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Has a sound knowledge of a variety of alternatives and their impact on their business unit.
Benefits
Comp & perks- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
post-market surveillancerisk assessmentsMedical Device Reports (MDRs)data analysisregulatory compliancecustomer communicationsinvestigation techniquescorrective actionstracking and trendingfield action activities
Soft Skills
collaborationcommunicationjudgmentproblem-solvingdata evaluationcross-functional teamworkwritten communicationattention to detailanalytical thinkingadaptability