Regulatory Affairs Specialist

Title: Regulatory Affairs Consultant

Location: New Delhi, India

The company

This is an established and experienced company specialised in tissue regeneration.

The Opportunity

Are you a seasoned professional in the medical device industry, ready to embark on a unique opportunity to drive real impact

We are seeking a Regulatory Affairs Consultant to join ideally as soon as possible a dynamic team in New Delhi, India.

The contract length will be between 3-6 months.

Your experience:

• 5+ years experience with Medical Devices
• Experience of product registration with Indian CDSCO
• Knowledge of compilation for Device Master File and Plant Master File for for Class A-B products, desirable C-D
• Knowledge of quality system SOPs related to. submission requirements

Please note: Due to the high volume of applications we sometimes receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.

Key skills we recruit for:

ISO 13485, 21 CFR 820, CE marking, MDR, Medical device regulation, MDD, medical devices, Digital health, 510 (K), PMA, Regulatory affairs, quality assurance, QA/RA, design quality, ISO 14971, combination devices, sterilisation, AIMDD , CER, PMCF

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