What are the responsibilities and job description for the Associate Regulatory Affairs Manager position at Katalyst CRO?
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.
- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
- 46 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.
