Regulatory Specialist at Sol-Millennium Medical Group, BSc Lifescience candidates apply now!
Welcome to Sol-Millennium Medical Group! We are a leading medical device company dedicated to delivering innovative and cutting-edge solutions to improve patient care and outcomes. At Sol-Millennium, we are committed to upholding the highest standards of quality and regulatory compliance to ensure the safety and efficacy of our products.
Job Title: Regulatory Specialist
About the job: 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 markets. 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 the 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 similar professional certification.
- Internal Auditor Training.
Keywords: Sol-Millennium Medical Group, Regulatory Specialist, U.S. FDA, Health Canada, Medical Device Industry, Regulatory Compliance
