Regulatry Affairs Specialist

vor 3 Stunden

Zürich, Schweiz Barrington James Limited Vollzeit
Regulatory Affairs Specialist

Are you a seasoned Regulatory Affairs Specialist looking to take the next step in your career within an organization that values innovation and quality? Are you ready to contribute to a rapidly growing spinal implant company and make a real impact by helping bring life-changing products to market? If so, we invite you to join our Regulatory Affairs team and support compliance with local and global regulatory standards

Key Responsibilities:
  1. As a Regulatory Affairs Specialist, you'll be crucial in ensuring our products comply with all applicable regulatory standards.
  2. Working alongside cross-functional teams, you'll navigate regulatory requirements and contribute to the smooth market entry of our medical devices globally.
  3. Prepare and maintain documentation for product registrations.
  4. Keep regulatory databases current.
  5. Oversee registration lifecycles in our Registration Information Management System.
  6. Assist in creating and updating MDR Technical Documentation.
  7. Support 510(k) submissions as needed.
  8. Collaborate with teams in R&D, marketing, and manufacturing to assess regulatory implications of project changes.
  9. Communicate with international agents, distributors, and authorities to oversee global product registrations.
  10. Assist in preparing PMS/PSUR reports for product evaluations.
  11. Participate in internal and external audits conducted by regulatory authorities.
  12. Support regulatory assessments for new standards and regulations.
  13. Collect, analyze, and interpret Regulatory Metrics and Key Performance Indicators.
Qualifications:
  • At least 3 years of recent experience in Regulatory Affairs.
  • Background in the medical device industry, with a solid understanding of Medical Device Regulation.
  • Strong communication skills, with the ability to clearly convey information across diverse teams.
  • Skilled in technical writing for structured documents, including protocols and reports.
  • Capable of compiling, organizing, and maintaining detailed regulatory files.
  • Proficiency in both English and French.
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