Associate Regulatory Affairs ManagerÂ
Associate Regulatory Affairs ManagerÂ
Posted on :
18-07-2025
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1 Vacancy
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Job Description
Responsibilities:
- The Associate Regulatory Affairs Manager will support the development review and submission of regulatory documents for medical device and IVD products.
- This role will assist in managing regulatory projects ensuring compliance with FDA ISO 13485 and other global regulatory requirements.
- The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle.
- Assist in the preparation review and submission of regulatory documentation for new products product changes and ongoing compliance.
- Support the regulatory submission process for 510(k) Technical Files and other regulatory filings.
- Provide regulatory guidance to cross-functional teams during product development and post-market activities under the direction of senior management.
- Help track and manage submission timelines regulatory project plans and documentation
- Stay informed on changes in FDA ISO 13485 IVDR and other global regulations communicating relevant updates to the team.
- Conduct regulatory assessments for product modifications and assist in defining appropriate submission strategies.
- Participate in internal and external audits inspections and regulatory agency communications as assigned.
- Contribute to the maintenance of regulatory files and submission records in accordance with internal procedures and regulations.
- May provide oversight and mentorship to junior staff or specialists on assigned projects.
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Requirements:
- Bachelors degree in Regulatory Affairs Life Sciences Engineering or a related field.
- 4 6 years of regulatory affairs experience in the medical device or IVD industry.
- Experience supporting or managing 510(k) submissions and regulatory filings.
- Familiarity with FDA regulations (21 CFR Part 820) ISO 13485 and international medical device regulations.
- Strong organizational document management and project coordination skills.
- Excellent communication problem-solving and cross-functional collaboration abilities.
- Detail-oriented with the ability to manage multiple regulatory projects and priorities.
- Proficient in Microsoft Office and regulatory document management systems.
- Ability to work independently and proactively while seeking guidance for complex issues.
Employment Type
Full-time
Key Skills
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