Senior Director of Regulatory Affairs
On-site - Greater Boston - Full Time
My client is a leading medical device company located north of Boston know for its technology in preserving organs. They are ultimately responsible for the increased volume of transplantable organs being made available so that more patients can benefit from life-saving transplant procedures. My client is looking to grow their team with a Sr. Director of Regulatory Affairs.
- Establish effective communication with executives and managers to ensure that company objectives and milestones are met, consistent with regulatory requirements.
- Regulatory lead for FDA as well as notified body audits for MDR, MDSAP, and QSR and BIMO compliance.
- Point of contact for submissions with FDA and international regulatory authorities.
- IDE and PMA applications, supplements, and reports as well as Technical Files and reports for EU MDR certification and other international registrations.
- Develop and implement strategies and tactics to obtain FDA and international regulatory approvals of Class III marketing applications and clinical trial applications in the US and internationally.
- Manage and mentor junior regulatory staff.
Preferred Skills, Qualifications and Technical Proficiencies:
- 12+ years within regulatory medical device industry.
- 5+ years management experience.
- Class III medical devices experience required.
- Successful international and FDA submissions including IDE and PMA applications, supplements, and reports and EU MDR/MDD technical documentation and reports required.
- Project management experience.
- Excellent oral and written communication skills.
- Experience with Class III cardiovascular devices a plus
- FDA regulations: 6 years (Required)
- BS in Engineering, Life or Biological Sciences, or related field; MS or PhD preferred
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
- Bonus Pay
Reliably commute or planning to relocate before starting work (Required)
Please don't hesitate to apply!