BioRad Medisys Pvt. Ltd. is hiring an experienced Regulatory Affairs Executive for its Medical Devices Division at Vemagal Industrial Area, Kolar, Karnataka. Candidates with experience in medical device regulatory affairs and global compliance are encouraged to apply.

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About BioRad Medisys Pvt. Ltd.

BioRad Medisys Pvt. Ltd. is a leading medical device manufacturing company committed to innovation, quality, and regulatory excellence. The company offers excellent career opportunities for professionals specializing in Regulatory Affairs, Quality Systems, and Medical Device Compliance.

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Job Details

Company: BioRad Medisys Pvt. Ltd.

Position: Regulatory Affairs Executive

Job Type: Full-Time

Job Location: Vemagal Industrial Area, Kolar, Karnataka

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Qualification

• B.E.
• B.Pharm
• M.Pharm
• Pharmacy / Life Sciences or related field

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Experience

• 3–6 Years

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Key Responsibilities

• Prepare, review, and maintain regulatory documents including DHF, DMR, and Technical Files.
• Ensure compliance with ISO 13485, US FDA, EU MDR, and applicable regulatory standards.
• Support product registrations, submissions, and regulatory approvals.
• Coordinate with QA, R&D, and Manufacturing teams for regulatory compliance.
• Handle change control, risk management, and post-market surveillance documentation.
• Support internal, external, and regulatory audits/inspections.
• Maintain regulatory records, product labeling, and technical documentation.
• Monitor global regulatory updates and implement necessary changes.

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Required Skills

• Strong knowledge of ISO 13485, EU MDR, US FDA, and GMP requirements.
• Experience in product registration and technical documentation.
• Good analytical, documentation, and communication skills.
• Experience in Medical Device Regulatory Affairs is mandatory.

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How to Apply

Interested candidates can send their updated resume to:

ananda.dk@bioradmedisys.com

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Documents Required

• Updated Resume
• Educational Certificates
• Experience Certificates
• Latest Salary Slip
• Passport Size Photograph
• Government ID Proof

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Important Note

• Candidates must have relevant experience in Medical Device Regulatory Affairs.
• Experience in ISO 13485, EU MDR, and US FDA regulations will be preferred.
• Only shortlisted candidates will be contacted.

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Frequently Asked Questions (FAQs)

Which position is available?

Regulatory Affairs Executive.

What qualification is required?

B.E., B.Pharm, M.Pharm, Pharmacy, Life Sciences, or related discipline.

How much experience is required?

3–6 years in Medical Device Regulatory Affairs.

What is the job location?

Vemagal Industrial Area, Kolar, Karnataka.

How can I apply?

Email your updated resume to ananda.dk@bioradmedisys.com.