Regulatory Specialist

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team.

Key Responsibilities

Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada.

Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews.

Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content.

Conduct regulatory impact assessments for design changes.

Qualifications

Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field.

Minimum of 3 years of regulatory experience in medical device industry.

Proven experience contributing to regulatory filings.

Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada.

Ability to interpret and apply regulatory requirements to complex technical issues.

Excellent communication, organization, and problem-solving skills.

Experience in supporting responses to regulatory agencies.

Ability to work independently and collaboratively in a cross-functional team environment.

Preferences

Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements.

Proven experience in contributing to international regulatory submissions.

RAC (Regulatory Affairs Certification) or simliar professional certification

Internal Auditor Training