Bachelor's 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 with 510(k) submissions and regulatory filings.
Familiarity with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
Strong organizational and document management skills.
Excellent communication and problem-solving abilities.
Detail-oriented with capacity to manage multiple projects.
Responsibilities
Support development, review, and submission of regulatory documents for medical devices and IVD products.
Assist in managing regulatory projects to ensure FDA and ISO 13485 compliance.
Work cross-functionally with teams to support product approvals and compliance maintenance.
Prepare and submit regulatory documentation for new products and changes.
Facilitate the regulatory submission process for 510(k) and Technical Files.
Provide regulatory guidance during product development and post-market activities.
Track and manage submission timelines and project plans.
Benefits
Mentorship opportunities for junior staff.
Exposure to a dynamic regulatory environment and cross-functional collaborations.
Chance to work on diverse projects across the product lifecycle.
Full 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.
ssist 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 project
Requirements:
Bachelor's 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.
