Regulatory Affairs Specialist

3 weeks ago

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 eCTD or electronic submission platforms.

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