Job Title

Job Title: Regulatory Affairs Junior ManagerLocation: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 andSaturday Half Day Preferred Gender: M/F Experience : Minimum 2 yearsJob Summary: We are seeking a proactive and detail-orientedRegulatory Affairs Executiveto support the regulatory compliance activities forClass 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. Minimum2 years of hands-on experiencein regulatory affairs, specifically withClass III medical devices . Knowledge of medical device regulations such asEU MDR ,US FDA 21 CFR Part 820 ,ISO 13485 , andCDSCOrequirements. 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.