Job Summary: We are seeking a Principal Regulatory Affairs Specialist to support regulatory strategies and submissions for Class III medical devices. This role will involve collaborating with cross-functional teams, contributing to the regulatory process for bringing innovative devices to market. You’ll play a key part in ensuring compliance with U.S. and international regulatory requirements, focusing on IDEs, PMAs, and other key submissions.
Key Responsibilities:
- Work with R&D and Operations teams to address regulatory requirements throughout product development.
- Support product testing and review, including risk management and document changes.
- Lead regulatory submissions for Class III devices and maintain regulatory communications.
- Oversee compliance with product packaging, labeling, and regulatory standards.
- Participate in audits and manage regulatory documentation across markets.
- Mentor junior team members and stay current on regulatory guidelines.
Qualifications:
- 10+ years in Regulatory Affairs, with experience in Class III medical devices.
- Proven track record with IDE and PMA submissions.
- Ability to navigate FDA and international regulatory standards.
- Strong communication, technical writing, and project management skills.
Additional Information:
- Hybrid role in a startup environment.
- Compensation ranges from $160k-$190k with equity and bonus potential.
