Principle Regulatory Affairs Specialist-Billerica, MA
Join a fast growing mid-sized Medical Device company
Limitless Growth Opportunity
About Our Client
Our client is a leading global provider of innovative medical devices for the treatment of peripheral vascular disease. They develop, manufacture and market disposable and implantable vascular devices to address the needs of vascular surgeons and interventionists. The Company is listed on NASDAQ.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The key responsibilities of the Principal Regulatory Specialist are:
- Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
- Provide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval.
- Review regulations and guidance to keep apprised of new regulatory developments.
The Successful Applicant
The successful Sr. Regulatory Affairs Specialist will have:
- Bachelor's Degree with a technical major
- 5+ years of experience in Medical Device
- Heavy experience with 510k submissions & CE Marking
- Strong technical writing skills
What's on Offer
This job offers base salary, bonus potential, and an attractive benefits package. There is also flexibility to work from home.