Job description
• Prepare, review, and maintain regulatory dossiers and technical documentation for domestic and international markets.
- Support submissions for EU IVDR, WHO PQ, ANVISA, and other applicable regulatory frameworks.
- Coordinate with QA, R&D, Manufacturing, and Marketing for regulatory compliance and submission requirements.
- Review product changes, labeling, claims, and supporting documents from a regulatory perspective.
- Monitor updates in global regulations and support implementation of applicable changes.
- Assist in responses to regulatory queries, audits, inspections, and external agency communications.
- Maintain regulatory records, licenses, registrations, and submission trackers in an organized manner.
- Ensure compliance with internal quality management systems and applicable standards.
Requirements
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or related discipline.
- 2–3 years of relevant experience in Regulatory Affairs within the medical device / IVD industry.
- Working knowledge of EU IVDR, WHO PQ, Brazil ANVISA, and other international medical device regulations.
- Familiarity with technical documentation, submissions, labeling, and change management.
- Understanding of ISO 13485, risk management principles, and regulatory documentation practices.
- Good documentation, analytical, coordination, verbal, and written communication skills.