Verified Job
Accounting - Finance
Regulatory Compliance Professional
Accounting - Finance
#584504
Remote / WFH
Job Description
Job description
International Regulatory Specialist
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• We are seeking a detail-oriented, experienced professional with a strong background in regulatory affairs to support our team.
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Key Responsibilities:
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• Support regulatory activities for international markets, focusing on U.S. FDA and Health Canada requirements.
• Contribute to and maintain regulatory documentation, including product regulatory files, IFUs, and labeling reviews.
• Collaborate with cross-functional teams to align regulatory documentation and submission content.
• Conduct regulatory impact assessments for design changes.
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Qualifications:
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• Bachelor of Science in Biomedical Engineering, Life Sciences, or related field.
• Minimum 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.
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Preferences:
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• 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.
International Regulatory Specialist
">
• We are seeking a detail-oriented, experienced professional with a strong background in regulatory affairs to support our team.
">
Key Responsibilities:
">
• Support regulatory activities for international markets, focusing on U.S. FDA and Health Canada requirements.
• Contribute to and maintain regulatory documentation, including product regulatory files, IFUs, and labeling reviews.
• Collaborate with cross-functional teams to align regulatory documentation and submission content.
• Conduct regulatory impact assessments for design changes.
">
Qualifications:
">
• Bachelor of Science in Biomedical Engineering, Life Sciences, or related field.
• Minimum 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.
">
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.
