Regulatory Affairs Manager II Post Market
WerfenMassachusetts, United States
Posted February 4, 2024
160000 - 190000 USD
Full Time
About the Company
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.
Job Description
The Regulatory Affairs Manager II leads the company’s post-market regulatory program to ensure global compliance for commercialized IL-labeled medical devices and manages a team of regulatory professionals in this endeavor. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements.
Requirements
- Lead, coach, and develop a team of post-market regulatory professionals
- Allocate resources and prioritize workload across markets/products for post-market regulatory activities
- Represent the RA Bedford function internally and externally
Benefits
- Medical, dental, and vision insurance
- 401k plan retirement benefits with an employer match
- Paid vacation and sick leave
- Commission plan for sales roles
- Performance-based bonus for management and select professional roles