Engineer II QA supporting quality management for manufacturing of medical devices at Arthrex. Responsible for audits, compliance, and training in a regulated industry.
About the role
- Regulatory Affairs Specialist ensuring compliance for cosmetics and OTC products. Collaborating with internal teams and managing submissions to Health Canada and FDA at NAOS in a hybrid work environment.
Responsibilities
- Ensure product compliance (cosmetics/OTC/DIN/PSN) with applicable Canadian and U.S. regulatory standards, at both federal and state levels
- Ensure annual renewal of establishment licences for drugs and natural health products
- Develop regulatory strategies
- Prepare documentation and submissions to Health Canada and the FDA: cosmetic notifications, DIN and PSN applications (Canada), and OTC submissions (USA)
- Monitor regulatory developments through professional cosmetics associations (Cosmetic Alliance, PCPC) and liaise with the NAOS Campus regulatory department (France)
- Communicate and implement action plans
- Interpret and communicate regulatory requirements; provide recommendations to internal teams and headquarters (R&D, Marketing, Supply Chain, Commercial)
- Serve as primary contact with regulatory authorities during inspections, follow-ups, or inquiries
- Develop local cosmetic and OTC artworks in collaboration with Marketing
- Validate cosmetic and OTC artworks
- Collaborate with Quality Assurance: develop and validate specification sheets for OTC components
- Maintain OTC regulatory files
- Communicate and implement any changes affecting OTC products
- Perform other related tasks in support of the Quality Assurance department as needed
- Monitor cosmetovigilance and pharmacovigilance
- Report RID information to Health Canada and/or the FDA.
Requirements
- Bilingual French/English (written and spoken)
- Good knowledge of Canadian and U.S. regulations for cosmetics and over-the-counter medicines
- 3 years' experience in Regulatory Affairs
- Three years of university-level studies in a scientific field
- Quality Assurance experience is a plus
- Knowledge of Quality principles
- Ability to work independently and reliably
- Ability to provide guidance and recommendations
- Problem-solving skills
- Ability to manage multiple projects simultaneously
- Strong organizational and communication skills
Benefits
- Remote work (1 day of telework per week)
- 25 days of vacation
- Health insurance coverage
- Comprehensive onboarding with product training
- Flat hierarchy with strong emphasis on personal initiative
- Strong team spirit
- Open, collegial company culture
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