Principal Regulatory Affairs Specialist

📋 Description

• Lead regulatory strategies for medical device products across global markets.
• Prepare, submit, and maintain registrations (FDA 510(k), EU Technical Documentation, STEDs).
• Coordinate with global/regional teams to align market-access submissions and timelines.
• Review labeling to meet U.S., EU, and international requirements.
• Monitor regulatory trends and provide guidance to stakeholders.
• Develop and maintain regulatory procedures, SOPs, and compliance processes.

🎯 Requirements

• Bachelor’s degree in a scientific field; advanced regulatory affairs knowledge valued.
• At least 5 years in regulatory affairs, preferably medical devices.
• Strong knowledge of FDA regulations and experience with STEDs/technical docs.
• Experience leading regulatory strategies and managing multi-market submissions.
• Understanding of lifecycle, labeling, and regulatory intelligence; strong project management.
• Excellent communication; ability to work independently and with cross-functional teams. Travel up

🎁 Benefits

• Salary range $80,900–$127,050; location/education/experience influence actual compensation.
• Remote work opportunity within the United States, up to 10% travel.
• Medical, dental, vision; HSA/FSA options.
• 401(k) savings plan; paid time off; parental leave; disability coverage.
• Flexible access to wages; well-being programs; inclusive workplace.
• Opportunity to work on complex regulatory initiatives for global market access.