Senior Manager

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Job details

Job Information

Date Opened 04/06/2026
Job Type Full time
Work Experience 5+ years
Industry Medical Device
City Vapi
State/Province Gujarat
Country India
Zip/Postal Code 396191

About Us

MERIL

DELIVERING WORLD-CLASS HEALTHCARE SOLUTIONS

Founded in 2006, Meril is an India-based, global medical device company that is dedicated to the innovation, design and development of novel, clinically relevant and state-of-the-art devices. Our fundamental aim is to champion the alleviation of human suffering and improve quality of life. To enable this, we are committed to R&D, innovation in manufacturing medical technology, scientific communication, and contemporary distribution avenues.

Meril was born with the aim of improving the quality of human life through innovative and advanced healthcare solutions. As a medical device manufacturer, we exist to improve the inventiveness in healthcare so that people's lives are enriched. We continually seek excellence in providing answers to some of medicine's toughest questions.

Meril manufactures medical solutions in the form of vascular intervention devices, orthopaedic supplements, in-vitro diagnostics, endo-surgery and ENT products. It is our core commitment to ensure the delivery of advance healthcare solutions. Our inclination towards research and development is reflected in our diverse offerings. We ensure that we adhere to the best quality of standards in manufacturing, scientific communication and distribution to deliver path-breaking healthcare products to the world.

We collaborate with physicians and global innovators to identify unmet clinical needs and develop revolutionary therapies. We encourage research and academic collaborations and remain available to interact on exciting opportunities.

Headquartered in India with a manpower of more than 4000, Meril currently conducts business in more than 100 countries. We have 100% subsidiaries in India, USA, Germany, Brazil, Russia, South Africa, Bangladesh and Turkey. We have set up operations in China and Japan too.

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.

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