Medical Device Regulatory Affairs Strategist

What you'll do

• Develop regulatory strategies for AI-enabled, cloud-native software products throughout the entire product lifecycle.
• Manage pre-market submissions including 510(k), CE Marking, and Technical Files for global markets.
• Maintain ongoing documentation and post-market surveillance reports to ensure continued market authorization.
• Serve as a subject matter expert on applicable standards, regulations, and quality management systems.
• Support internal and external audits to identify and remediate risks or compliance deficiencies.
• Manage compliance projects specifically related to health products and global regulatory requirements.
• Review and recommend changes to labeling, marketing communications, clinical protocols, and manufacturing procedures.

What we're looking for

• Candidates must have 10+ years of experience for the principal level.
• A BA, BS, or advanced degree is preferred.
• Experience in medical device industry regulatory affairs, quality compliance, or product development is required.
• Experience authoring submissions such as 510(k) and EU Tech Files is required.
• Experience working within a quality management system including ISO 13485 and ISO 14971 is preferred.
• Certifications such as RAC, CQE, CPPS, or CQA are desired.
• Proficiency in English reading, writing, and speaking is required.
• Ability to perform in a fast-paced environment with excellent written and verbal communication skills.