Regulatory Affairs Specialist

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 :

Preferred Qualifications :