Senior Post Market Compliance Specialist
WerfenSan Diego, California, United States
Posted October 17, 2023
85000 - 127000 USD year
Full Time
About the Company
Werfen is a global leader in specialized diagnostics, headquartered in Barcelona, Spain. With a focus on Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant, the company offers a range of In Vitro Diagnostics (IVD) products and services. Known for its innovation and presence in 30 countries, Werfen employs over 7,000 people and achieved nearly €2.2 billion in worldwide sales in 2024.
Job Description
This Senior Post Market Compliance Specialist role will ensure compliance for on-market devices with post market global regulations. The position will lead cross-functional teams in post market assessments and execution of surveillance, reportability, vigilance, and field actions. The specialist will represent Werfen in interactions with regulatory authorities and provide support to Regulatory Affairs functions in CAPA (Corrective and Preventive Action) and Design Control.
Requirements
- Minimum 7 years of progressive quality/regulatory/post market compliance experience in in-vitro diagnostics and/or medical device industry
- 4 years of experience managing post market compliance activities, including post-market surveillance, field actions, vigilance, and field actions.
- Advanced communication and analytical skills.
- Ability to lead cross-functional teams.
- Strong understanding of in-vitro diagnostics (IVD) regulations.
Benefits
- Competitive salary
- Equal Opportunity Employer
- Diverse workplace
