• 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.
• Valuable documentation, analytical, coordination,
verbal, and written communication skills.