Senior Manager, Regulatory Affairs -Medical Device
Leads submissions for new medical device in Europe and other regions
This company is a top-rated medical manufacturer based in the Boston Area
About Our Client
Our latest client is a medical device manufacturer based in the Greater Boston Area. While the company is established, its operations run very much so in comparison to a "start-up" environment where everyone "wears many hats."
- Write submission documents for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction. Develop responses to questions or deficiency letters from regulatory agencies.
- Design and implement transition plan to new MDR regulation
- Design a system to identify and gather clinical data
- Compile clinical evaluation reports for 60 separate projects
- Maintain MDR system once implemented
- Maintain MDR compliance
- Manage and maintain EUDAMED systems including the handling of complaints, post market surveillance, clinical evaluation reports and UDI, etc.
- Register products in Europe, ensure they receive CE marks
- Maintain and update CE Certificates with new product codes
- Proactively partner with R&D, Marketing and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets. Develop and approve appropriate technical documents for regulatory submissions in support of the development project. Advertising, labeling, and promotional materials are included in technical documentation.
- Develop and maintain Technical Files for CE marking, with limited guidance and direction.
- Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging.
- Participate as a member of new product development teams to provide regulatory support to the project.
The Successful Applicant
- B.S. in a technical discipline require
- 5 years' experience in regulatory affairs within the medical device industry
- Strong experience in EU Regulations is required
- Experience in FDA submissions required
- Experience in writing/maintaining CE Technical Files preferred
- Experience in Canadian medical device licensing preferred
What's on Offer
- Strong base salary
- Management role with direct reports
- Competitive benefits package
- Voted top-rated company to work for in New England
- Great training and development
- Visibility to senior leadership
- Ample opportunity for promotions and growth
- Market leader within its medical device type