Meril Regulatory Affairs Recruitment
Meril Diagnostic Pvt. Ltd. is inviting applications for Officer, Executive, Assistant Manager, and Manager – Regulatory Affairs positions at its Vapi, Gujarat facility. This opportunity is ideal for professionals with experience in Medical Devices and In Vitro Diagnostics (IVD) Regulatory Affairs. Candidates with expertise in regulatory submissions, technical documentation, ISO 13485, CE IVDR, WHO PQ, and global regulatory frameworks are encouraged to apply.

Company
Meril Diagnostic Pvt. Ltd.

Positions

Officer – Regulatory Affairs
Executive – Regulatory Affairs
Assistant Manager – Regulatory Affairs
Manager – Regulatory Affairs

Job Location
Vapi, Gujarat

Department
Regulatory Affairs (Medical Devices / IVD)

Job Responsibilities
Officer / Executive – Regulatory Affairs

Prepare regulatory dossiers and technical documentation for IVD products.
Draft SOPs, validation protocols, stability study protocols, and performance study protocols.
Support risk management documentation and regulatory lifecycle activities.
Coordinate dossier compilation and documentation review for domestic and international submissions.
Ensure compliance with ISO 13485 and applicable regulatory requirements.
Support product registrations, regulatory documentation, and change control activities.

Assistant Manager / Manager – Regulatory Affairs

Prepare, review, and maintain regulatory dossiers for domestic and international markets.
Lead regulatory submissions for EU IVDR, WHO PQ, ANVISA (Brazil), BIS, and other global regulatory agencies.
Collaborate with QA, R&D;, Manufacturing, and Marketing throughout the product lifecycle.
Review product changes, labeling, artwork, product claims, and technical documentation.
Monitor changes in global regulations and implement regulatory updates.
Respond to regulatory authority queries, audits, inspections, and compliance requirements.




Maintain regulatory licenses, registrations, submission trackers, and compliance records.
Ensure compliance with ISO 13485, Quality Management Systems (QMS), and risk management principles.

Eligibility Criteria
Educational Qualification

B.Pharm
M.Pharm
B.Sc Life Sciences
M.Sc Life Sciences
Biotechnology
Biomedical Engineering
Other Related Scientific Disciplines

Experience

Relevant Regulatory Affairs experience in Medical Devices or IVD Industry.
5+ years of manufacturing experience is preferred for senior positions.

Required Skills

Regulatory Affairs
Medical Device Regulations
In Vitro Diagnostics (IVD)
CE IVDR (EU 2017/746)
WHO Prequalification (WHO PQ)
ANVISA Regulations
BIS Regulations
ISO 13485
Technical Documentation
Regulatory Dossier Preparation
Product Registration
Stability Study Protocols
Validation Protocols
Performance Study Protocols
Risk Management Documentation
SOP Preparation
Quality Management Systems (QMS)
Change Control
Regulatory Compliance
Documentation Review
Robust Communication Skills

Preferred Candidate Profile

Experience with global regulatory submissions.
Strong analytical and documentation skills.
Excellent coordination and cross-functional collaboration abilities.
Experience working in Medical Devices or IVD manufacturing.

How to Apply
Interested and eligible candidates can apply online using the application form below.

Application Form:

https://forms.zohopublic.in/merillifesciencespvtltd688/form/HiringforOfficerExecutiveRegulatoryAffairsWHOCEatM/formperma/h-Krp-oRQ3tQCYE7CXTjg7G_KBRYFu27AKWd2MrEJfM

Job Summary

Company
Meril Diagnostic Pvt. Ltd.

Vacancies
Officer, Executive, Assistant Manager, Manager – Regulatory Affairs

Required Education
B.Pharm, M.Pharm, Life Sciences, Biotechnology, Biomedical Engineering, or Related Scientific Degree

Experience
Relevant Regulatory Affairs Experience (5+ Years Preferred for Senior Positions)

📌 Hiring for Officer / Executive / Assistant Manager – Regulatory (Valsad)
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