A leading medical devices firm is seeking an experienced Regulatory Affairs Specialist to join their growing team in Bangalore. As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements for medical devices.
About the Role
Job Title: Regulatory Affairs Specialist
Location: Bangalore
Experience: 3+ years
Industry: Medical Devices (Class IIb devices preferred)
Responsibilities
Documentation: Prepare and compile design and development documentation, risk management reports, and technical files as per EU MDR, USFDA, and ISO 13485.
Regulatory Submissions: Handle CDSCO submissions and documentation for manufacturing/import licenses.
Compliance: Ensure compliance with FDA, CE-MDR, ISO 14971, and cGMP standards.
Post-Market Surveillance: Support post-market surveillance, PMCF, and clinical evaluation activities.
Requirements
Experience: Minimum 3+ years of experience in Regulatory Affairs (Class IIb devices preferred).
Skills:
Strong technical writing and documentation skills.
Detail-oriented, proactive, and a great team player.
Knowledge:
Knowledge of regulatory requirements for medical devices, including EU MDR, USFDA, and ISO 13485.
Experience with CDSCO submissions and documentation.
What We Offer
Career Growth: Opportunities for professional growth and development in a rapidly evolving industry.
Collaborate with a global team and contribute to the development of life-changing medical devices.
Professional Development: Opportunities for professional growth and development in a rapidly evolving industry.
Competitive Benefits: Attractive salary and benefits package.
Why Choose This Leading Medical Devices Firm?
Innovative Culture: Opportunity to work with a team that’s driving innovation in medical devices.
Global Reach: Collaborate with a global team and contribute to the development of life-changing medical devices.
Professional Development: Opportunities for professional growth and development in a rapidly evolving industry.
📧 Interested?
If you’re ready to make an impact in medical device compliance, send your CV to santosh@peoplefirst.co.in
or DM us to learn more! 💬
Regulatory affairs and pharmacist
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