Regulatory Affairs Specialist

3 weeks ago

Ahmedabad, India Frisch Medical Devices PVT LTD Full time

Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej CrossroadsDepartment: RAReports To: RA Head and Regulatory Department at HO /DirectorEmployment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half DayPreferred Gender : M/FExperience : Minimum 2 yearsJob 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 eCTD or electronic submission platforms.

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