- Independently authors standard sections of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS), Post Market Clinical Follow-up (PMCF), and Summary of Safety and Clinical Performance (SSCP) documents
- Executes NJR analysis and literature search strategies and documents appraisal outcomes
- Drafts clinical safety and performance summaries and benefit-risk analyses
- Ensures traceability across data sources and regulatory requirements
- Maintains template compliance and audit-ready documentation
- Coordinates with Regulatory, Clinical, and Development partners to finalize drafts
- Supports methodological consistency across product lines
- Participates in internal peer reviews
- Manages timelines for assigned deliverables
- Follows established procedures
- Performs quality control checks for formatting, references, and traceability
- Ability to escape and resolve compliance or risk concerns
- Strong scientific and technical writing skills
- Basic working knowledge of medical device clinical and regulatory documentation
- Ability to execute literature strategies and appraise evidence
- Ability to analyze National Joint Registry (NJR) data
- Understanding of global medical device regulations and post-market obligations
- Strong analytical and data synthesis skills
- Effective cross-functional communication
- Ability to manage multiple documents and deadlines
- High attention to detail and commitment to accuracy Willingness to learn regulatory requirements
- Organizational skills and ability to manage multiple deliverables
- Awareness of audit/inspection readiness and compliance expectations
- Bachelor's Degree in Health, Life Sciences or related field and 2 years of relevant experience, or Associate's Degree and 4 years of relevant experience, or Secondary School Degree or Equivalent and 6 years of relevant experience
- Preferred:
Degree in Health, Life Sciences or related field - Preferred: 2+ years experience in medical or regulatory writing
- Up to 5 %
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.
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