Regulatory affairs specialist

3 days ago

Ahmedabad, India Frisch Medical Devices PVT LTD Full time

Job Title: Regulatory Affairs Junior Manager Location: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday and Saturday Half Day Preferred Gender : M/F Experience : Minimum 2 years Job Summary: We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management. Key Responsibilities: Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.). Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments. Support product development teams with regulatory input during the design and development phases. Conduct regulatory impact assessments for design or process changes. Monitor and interpret evolving global regulations and standards applicable to Class III medical devices. Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits. Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations. Assist in internal audits and inspections, including document preparation and response coordination. Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements. Participate in risk management, clinical evaluation, and post-market surveillance activities. Qualifications: Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices . Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements. Experience in dossier preparation (e.g., 510(k), PMA, CE technical files). Strong analytical, organizational, and communication skills. Attention to detail and ability to work independently as well as in a team environment. Preferred Qualifications: Certification in Regulatory Affairs (e.g., RAC) is a plus. Experience interacting with regulatory bodies or notified bodies. Familiarity with e CTD or electronic submission platforms.

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