Life Science Jobs at Sol-Millennium Medical Group | Apply Now for Regulatory Specialist Role
Are you looking for an exciting opportunity in the medical device industry? Sol-Millennium Medical Group is hiring a Regulatory Specialist with proven expertise in international regulatory submissions and compliance. This role focuses on U.S. FDA and Health Canada regulations, supporting product development through post-market activities. If you have a strong background in regulatory affairs, documentation, and cross-functional collaboration, join us to make an impact on global healthcare solutions.
About Sol-Millennium Medical Group
Sol-Millennium Medical Group is a leading company in the medical device industry, focused on innovation and quality in healthcare solutions. We pride ourselves on a commitment to regulatory compliance and delivering products that meet the highest standards of safety and efficacy. Our team is dedicated to making a positive impact on global healthcare through our products and services.
Job Details
- Job Title: Regulatory Specialist
- Location: Remote/Onsite
- Employment Type: Full-time
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, with 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.
Description
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 on 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, focusing on the 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.
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, Medical Device Industry, U.S. FDA, Health Canada, Regulatory Compliance, Quality Engineering, Life Science Jobs at Sol-Millennium, RAC Certification, Job Posting
