Post-market Clinical Evidence Associate

hace 1 día

Madrid, España Institut Straumann AG A tiempo completo

Post-Market Clinical Evidence Associate (Madrid, Spain)

We are seeking a qualified professional with proven experience in Clinical, Post-Market, or Regulatory functions within the medical device industry. This position is part of Straumann’s Real-World Evidence Team and is primarily responsible for the development and maintenance of Post-Market Clinical Follow-up (PMCF) Plans and Reports in alignment with EU MDR requirements. The role also includes a supporting contribution to Clinical Evaluation and Post-Market Surveillance documentation, in close coordination with cross-functional teams.

Key Responsibilities:

- Develop and maintain PMCF Plans and PMCF Evaluation Reports in accordance with EU MDR requirements
- Evaluate and synthesize clinical data from diverse sources, including clinical investigations, registries, literature, and scientific meetings
- Support the integration of PMCF outputs into Clinical Evaluation Reports (CERs) and Periodic Safety Update Reports (PSURs)
- Ensure consistency, traceability, and quality of data and content across all documents
- Maintain regulatory compliance across all documentation and contribute to audit readiness

Required Qualifications:

- Master’s degree (or higher) in Life Sciences, Medical, or related field
- Minimum 2 years of experience in Clinical, Post-Market, or Regulatory functions within a MedTech company
- Strong understanding of EU MDR requirements, particularly related to clinical evaluation and post-market surveillance
- Experience working with clinical and scientific data and translating it into regulatory documentation
- Proficiency in spoken and written English
- Structured, pragmatic, and proactive working style
- Excellent interpersonal skills, ability to work collaboratively in a matrix organization.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

**Employment Type**:Full Time

**Alternative Locations**:Spain : Madrid

**Travel Percentage**:0 - 10%

**Requisition ID**:18104

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