Senior Manager

• 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.

• 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.