Contract Duration: 4-6 months, potential conversion to FTE after initial contract

Job Summary:

We are seeking an experienced and detail-oriented Senior Regulatory Specialist to work on a core project team which will author an original Premarket Approval (PMA) application for a Class III neurovascular device. The successful candidate will play a crucial role in ensuring that our innovative medical device meets all regulatory requirements for approval, working closely with cross-functional teams, including R&D, Quality, and Clinical Affairs. This position requires in-depth knowledge of FDA regulations, exceptional project management skills, and a proven track record in regulatory submissions for Class III medical devices.

Qualifications:

• Bachelor’s degree in a life sciences, engineering, or related field; advanced degree preferred.
• Minimum of 5-7 years of experience in regulatory affairs within the medical device industry, with specific experience in PMA submissions.
• In-depth knowledge of FDA regulations, guidance documents, and submission requirements for Class III medical devices.
• Strong project management skills, with the ability to manage multiple priorities and deadlines in a fast-paced environment.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory requirements to cross-functional teams and external stakeholders.
• High level of attention to detail, ensuring accuracy and completeness in all aspects of regulatory documentation and submissions.
• Strong analytical and problem-solving skills, with the ability to develop creative solutions to regulatory challenges.
• RAC (Regulatory Affairs Certification) is a plus.