
International Regulatory Compliance Specialist
2 weeks ago
We are seeking a skilled regulatory professional to lead international market activities and ensure compliance with U.S. FDA and Health Canada regulations.
Key Responsibilities:
- Regulatory strategy development for global markets, focusing on U.S. and Canadian requirements.
- Maintenance of regulatory documentation, including product files, IFUs, and labeling reviews.
- Collaboration with cross-functional teams to align regulatory content and submissions.
- Regulatory impact assessments for design changes and emerging issues.
Qualifications:
- Bachelor's degree in Biomedical Engineering, Life Sciences, or related field.
- Minimum 3 years of experience in regulatory affairs, preferably in the medical device industry.
- Proven track record of contributing to regulatory filings and submissions.
- Strong understanding of international regulatory frameworks, with emphasis on U.S. FDA and Health Canada.
- Ability to interpret and apply complex regulatory requirements to technical issues.
- Excellent communication, organizational, and problem-solving skills.
- Experience in supporting responses to regulatory agencies and audit preparation.
- Capacity to work independently and collaboratively in a team environment.
Preferred Qualifications:
- Background in Quality Engineering to ensure alignment between regulatory strategy and quality system requirements.
- Proven experience in contributing to international regulatory submissions and certification processes.
- Regulatory Affairs Certification (RAC) or similar professional certification.
- Internal Auditor Training to enhance regulatory compliance and risk management.
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