Regulatry Affairs Specialist

Zürich
05-11-2024
Job Type
Permanent
Emp Type
Full Time
Functional Expertise
Regulatory Affairs
Salary Type
Annual

Job Description

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:
 
As a Regulatory Affairs Specialist, you'll be crucial in ensuring our products comply with all applicable regulatory standards. Working alongside cross-functional teams, you'll navigate regulatory requirements and contribute to the smooth market entry of our medical devices globally.
  • Prepare and maintain documentation for product registrations
  • Keep regulatory databases current
  • Oversee registration lifecycles in our Registration Information Management System
  • Assist in creating and updating MDR Technical Documentation
  • Support 510(k) submissions as needed
  • Collaborate with teams in R&D, marketing, and manufacturing to assess regulatory implications of project changes
  • Communicate with international agents, distributors, and authorities to oversee global product registrations
  • Assist in preparing PMS/PSUR reports for product evaluations
  • Participate in internal and external audits conducted by regulatory authorities
  • Support regulatory assessments for new standards and regulations
  • 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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Consultant

Karin Achermann-Danioth