Overview In this Principal Specialist role, you drive regulatory activities for a medical device portfolio across the US, EU and global markets. You will shape regulatory strategies, assess changes, and support submissions to maintain market access and compliance through the product lifecycle. You'll collaborate with Regulatory Affairs, R&D, Quality, Marketing and Operations to inform sound business decisions. The role focuses on lifecycle management, timely submissions and approvals, and enabling product changes within regulatory boundaries. This is a chance to influence global market access in a mission-driven healthcare company.
Compensation / Benefits- medical and dental coverage from day one
- 401(k) plan with company matching
- Employee Stock Purchase Plan (ESPP)
- paid time off 20-35 days depending on length of service
- paid holidays
- educational assistance programs
Responsibilities- Manage regulatory approvals, registrations and change assessments to ensure ongoing compliance and market availability
- Develop regulatory strategies and submission plans for product and process changes and new market introductions
- Evaluate regulatory impact and determine submission requirements for US, EU and international markets
- Prepare and submit US filings including 510(k), pre-submissions and responses to FDA requests
- Maintain EU MDR documentation and support updates to technical documentation
- Support interactions with Notified Bodies and regulatory authorities for assigned products
- Review technical, scientific and quality information to assess regulatory impact and support lifecycle changes
- Monitor regulatory changes and assess impacts on products, processes and strategies
- Partner with cross-functional and international regulatory teams to plan, execute and ensure compliance
Key requirements- Bachelor's degree in scientific or engineering subject area
- 5 years regulatory experience in the medical device industry
- Experience with electromechanical medical devices (desirable)
- Experience with FDA change assessment guidance and EU MDR technical documentation expectations
- Ability to document regulatory decisions and defend submission strategy
- Successful preparation and submission of 510(k)s
- Familiarity with global registrations beyond US and EU
- Strong regulatory knowledge to interpret scientific information for submissions
- Ability to influence cross-functional partners in a matrixed global organization
- Ability to manage multiple projects and timelines in a multinational team
- Strong oral and written communication and presentation skills
- Strong negotiation skills
- Identify, prioritize and communicate regulatory risks and raise issues when appropriate
- influencing cross-functional partners
- strong communication
- negotiation skills
- FDA 510(k) submissions
- EU MDR documentation and regulatory strategy
- Notified Bodies interactions
