Senior Director - Medical Device Regulatory Affairs
Location: Ideally you're in or near Boston (and can work hybrid in office/remote) but we are also open to fully remote (with some travel)
Skills: You'll need a solid background in RA and several yrs experience with implantable medical devices
Comp: 200-250k base + bonus + equity + full benefits
Stellar opportunity to join an implantable cardiac medical device company at an early stage! If you are seeking a startup and hence an opportunity to make a huge impact then keep reading.......
Top Reasons to Work with Us
- Pre IPO valuation at $800m! One of the best funded startups in the history of medtech.
- Great team culture. Work with people who love what they do.
- Opportunity to work on a unique product which is one of the most complex and sophisticated implantable medical devices and will save millions of lives.
- Excellent career advancement potential.
- Join a US startup owned by a highly successful company. Get the fun of a startup but with financial stability!
What You Will Be Doing
- Provide regulatory leadership and work in a team environment with external and internal stakeholders
- Develop regulatory strategic plans in conjunction with project teams and lead all aspects of the regulatory programs required for regulatory approval/maintenance
- Interact with key personnel at regulatory agencies to ensure the review and approval of submissions, the timely resolution of issues and the approval of applications
- Promote team growth and expand capability by providing regulatory training to relevant personnel related to premarket submission, product labelling, and complex submission issues
- Prepare submission packages for regulatory agencies, including Q-Sub, IDE, PMA, CE Mark, etc.
- Submit documents to regulatory agencies, including FDA and relevant Competent Authorities; manage communication and follow-up deliverables
- Establish and maintain policies, guidelines, and procedures for the regulatory affairs department
- Collaborate with commercial team to develop the regulatory strategy and maintain regulatory plan
- Manage and maintain RA budget and RA project timeline
- Provide regulatory support on project teams including QMS, labelling, promotional materials, change controls, etc.
- Ensure product launches and distribution complies with applicable regulations
- Collaborate with functional teams on complaint investigations, MDR reporting and field actions (product recall, field safety notice, etc.), as needed
- Manage US post-approval reports, export certificates, and establishment registrations and device listings
- Maintain product technical files for ongoing activities related to US and CE regulatory compliance
What You Need for this Position
- Preferably a degree in a relevant field
- Strong experience with implantable medical devices
- Strong background with FDA Regulatory Affairs, preferably at the Director level
- Comfortable with the fast pace and scrappy nature of a startup!
Nice to have:
- Panel reviews
- Global experience, especially Europe
What's In It for You
- Medical, Dental, and Vision insurance through Blue Shield & Kaiser; both HMO/PPO options; company pays $480 per employee or $960 per employee + Family per month
- 10 paid holidays
- Annual bonus
So if you fit the bill, please apply today!
Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Sally Janavicius
Applicants must be authorized to work in the U.S.CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work
- In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.