What are the responsibilities and job description for the Sr. Regulatory Affairs Associate position at Bridgeway Partners, Inc.?
Senior Regulatory Affairs Associate – Medical Device
We are partnering with an innovative medical device company seeking a Senior Regulatory Affairs Associate to support regulatory strategy and submissions for new and existing products.
This individual will work closely with engineering, quality, and product development teams to guide regulatory activities throughout the product lifecycle.
Key Responsibilities
- Prepare and support FDA 510(k) submissions and other regulatory filings.
- Coordinate international regulatory submissions and global product registrations.
- Interpret and apply EU MDR requirements during product development and market expansion.
- Identify applicable standards and ensure compliance with IEC 60601 and other medical electrical equipment requirements.
- Interface with third-party testing laboratories for electrical safety, EMC, and related compliance testing.
- Provide regulatory input to cross-functional teams during product development and design changes.
Qualifications
- Experience supporting regulatory submissions for medical devices.
- Working knowledge of FDA regulatory pathways and global regulatory requirements.
- Familiarity with EU MDR frameworks and international product approvals.
- Experience coordinating with external test labs and applying electrical safety standards.
- Ability to collaborate effectively with engineering and quality teams in a fast-paced development environment.