Regulatory Affairs Executive

Company Description

Meril, established in 2006, specializes in designing, manufacturing, and distributing state-of-the-art and high-quality medical devices focused on improving patient care and quality of life. With a commitment to research and development, Meril adheres to the highest standards in manufacturing, scientific communication, and distribution. As part of a health-care diversification initiative by a large Indian multinational company, Meril strives to make innovative healthcare solutions accessible. For more information, visit: Meril.

Executive – Regulatory Affairs

Medical Devices / In Vitro Diagnostics (IVD)

Job Purpose

We are seeking a motivated and detail-oriented Regulatory Affairs professional with 2–3 years of experience in the medical device / IVD industry. The candidate will support regulatory submissions, maintenance of technical documentation, and compliance with applicable global regulatory requirements, including EU IVDR, WHO Prequalification, Brazil ANVISA, and other relevant international standards and regulations.

Key Responsibilities:

• 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.

Qualifications :

Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or related discipline.

Experience & Skill:

• 3-5 years of relevant experience in Regulatory Affairs within the medical device / IVD industry.

• Familiarity with technical documentation, submissions, labeling, and change management.

• Working knowledge of EU IVDR, WHO PQ, Brazil ANVISA, and other international medical device regulations.

• Understanding of ISO 13485, risk management principles, and regulatory documentation practices.

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

Preferred Attributes :

• Exposure to multiple global markets and regulatory pathways.

• Basic understanding of post-market surveillance and vigilance requirements.

• Proactive, organized, and compliance-oriented approach.