Medical Device Safety Expert

12 hours ago


Reading, Reading, United Kingdom Bayer AG Full time
Company Overview

Bayer AG is a leading healthcare company with a strong commitment to innovation and patient care.

Job Summary

We are seeking an experienced Senior Medical Device Risk Manager to lead our medical device safety efforts globally. As a key member of our pharmacovigilance team, you will be responsible for implementing medical device safety standards and ensuring compliance with regulatory requirements.

Key Responsibilities
  1. Develop and implement medical device safety strategies in accordance with global regulations.
  2. Manage post-market surveillance (PMS) activities, including trend analysis and reporting.
  3. Provide design control contributions to new product development (NPD) processes.
  4. Represent the organization during Health Authority inspections and Notified Body audits.
Requirements
  • Master's degree in Engineering or Life Sciences with significant experience in medical devices.
  • Expert knowledge of medical device regulations, such as 21 CFR Parts 803, 806, and 820.
  • Strong leadership and communication skills.
Benefits
  • Competitive salary: $120,000 - $150,000 per year.
  • Benefits package includes health insurance, pension plan, and paid time off.
  • Opportunities for professional growth and development.


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