At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
As a Clinical Post Market Surveillance Sr Specialist, you will independently lead Post Market Surveillance (PMS) activities for assigned products. You will serve as a subject matter expert for PMS documentation, Post Market Clinical Follow-up (PMCF) commitments, trend analyses, and cross-functional coordination. You will provide guidance, mentorship, and technical oversight for less experienced PMS staff.
How You’ll Create Impact
- Leads authorship of PMPSs, Periodic Safety Update Reports (PSUR), PMS Reports, and PMCF-related documentation for complex or high-risk product families.
- Performs quality control checks for formatting, references, and traceability.
- Performs in-depth trend analyses of PMS and complaint data, escalating potential safety signals as appropriate.
- Interprets multi-source clinical and safety data to develop evidence-based conclusions.
- Advises product teams on corrective actions, monitoring thresholds, and risk mitigation strategies.
- Serves as document owner for PMS Plans, Periodic Safety Update Reports and PMS reporting.
- Partners with Regulatory Affairs to ensure PMS documentation alignment and Notified Body readiness.
- Provides expert peer review and mentorship to Specialists and Associate clinical PMS Specialists.
- Troubleshoots Notified Body or internal QA questions related to PMS evidence, trends, or data integrity.
- Supports audit readiness and participates in internal, external, and Notified Body audits/inspections by preparing, reviewing, and defending PMS-related documentation, evidence, data, and responses.
- Tracks execution of PMS plans, monitors risks or delays, and communicates status to senior stakeholders.
- Contributes to improvements in templates, methodologies, and writing standards.
What Makes You Stand Out
- Independent ownership of PMS processes and documentation
- Strong working knowledge of global PMS regulations (EU MDR, FDA, ISO 14155)
- Advanced analytical skills, critical thinking and ability to interpret multi-source data
- Effective cross-functional communication and influence without authority
- High attention to detail, audit-readiness, and inspection preparedness
- Ability to efficiently prioritize multiple project tasks simultaneously, focusing on critical aspects while maintaining strategic oversight to deliver high-quality results and meet deadlines
- Ability to elevate and resolve compliance or risk concerns
Your Background
You hold a degree in Health, Life Sciences, or related field combined with at least 4 years of relevant experience in medical device across Clinical, Regulatory, or Quality department.
Travel Expectations
Up to 5%.
EOE/M/F/Vet/Disability
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