Regulatory Affairs Specialist

4 weeks ago

Ahmedabad, Gujarat, 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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