Serve as a regulatory partner to R&D, Quality, Clinical, Manufacturing, Operations, and Marketing teams across NPI and sustaining activities
Independently assess regulatory impact for new products and changes, and provide clear regulatory pathway recommendations
Develop and maintain regulatory strategies aligned with business priorities and evolving regulatory requirements
Interpret and apply applicable regulations, standards, and guidance (e.g., FDA, EU MDR, Health Canada and ROW) and translate them into practical development guidance
Review and approve R&D, quality, preclinical, and clinical documentation for regulatory submissions
Compile, prepare, review, and submit high-quality regulatory submissions in the U.S., EU, and Canada; support international filings as needed
Support regulatory authority interactions by drafting briefing materials, responses, and correspondence
Prepare and maintain licenses, registrations, and listings for assigned geographies
Support product safety reporting (e.g., MDR, Vigilance), recalls, audits, and regulatory inspections
Maintain regulatory files, systems, and tracking databases
Identify emerging regulatory issues and proactively provide guidance to functional teams
Exercise sound, ethical judgment in compliance with regulations and company policy
Manage multiple priorities concurrently with accuracy and accountability
Owns regulatory assessments and change impact determinations
Develops regulatory pathway options and brings clear recommendations

7+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices
Demonstrated experience with pre
and post-market medical device submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers
Experience in the use of clinical data to support regulatory submissions (e.g. expansion of indications)
Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus
Strong ability to interpret regulations, identify regulatory data needs, and solve regulatory issues
Ability to balance detailed execution with broader regulatory strategy development
Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993
Bachelor's degree Engineering/ Life Sciences (advanced degree preferred)
RAC certification (U.S. or EU) is a plus
Demonstrated ability to work independently and collaboratively in a fast-paced, ambiguous environment
Strong judgment and comfort making regulatory recommendations under uncertainty
Clear, concise verbal and written communication skills across diverse audiences
Highly organized with strong prioritization and project management skills
Proficiency in MS Word, Excel, PowerPoint, and Adobe

Senior Regulatory Affairs Specialist

Key skills