Regulatory Affairs Professional

Job Requirements

About the Role

Seeking an experienced Regulatory Affairs Professional to lead / manage regulatory compliance activities for our Medical Device and In-Vitro Diagnostic (IVD) manufacturing operations. The ideal candidate will have strong expertise in Indian & international medical device regulations, regulatory submissions, quality management systems & liaison with government authorities & certification bodies.

The role requires a proactive professional who can ensure complete regulatory compliance while supporting new product registrations, manufacturing license approvals, market expansion initiatives, and continuous compliance with applicable standards and regulations.

Key Responsibilities

• Regulatory Affairs & Licensing
• Prepare, review & submit applications for: Manufacturing licenses for IVD assays, consumables & related products. Product registrations & approvals with CDSCO and State FDA authorities. Amendments, renewals & regulatory variations as applicable. Ensure compliance with Medical Devices Rules (MDR) 2017 & related regulatory requirements.
• Act as the primary point of contact with CDSCO, State FDA & other regulatory authorities.
• Respond to regulatory queries, deficiency letters, inspections & audits.

International Regulatory Compliance

• Coordinate and support regulatory filings and approvals for: CE Marking/ US FDA submissions/ MDSAP requirements/ WHO-related applications and registrations

Quality & Compliance Management

Ensure continued compliance with: ISO 13485/ ISO 9001, MDR 2017 Applicable national and international regulatory requirements. Support internal, external, certification, customer, and regulatory audits & collaborate with R&D, QA & Operations teams to maintain regulatory compliance.

• Qualifications: Bachelor's / Master’s degree in: Pharmacy/ Life Sciences/ Microbio/ Biotechnology/Regulatory Affairs

Experience

• Minimum 8-12 years of relevant experience in RA within: In-Vitro Diagnostic (IVD) Manufacturing
• Proven experience in obtaining manufacturing licenses & RA from CDSCO / State FDA authorities.
• Experience handling international regulatory submissions & certifications.
• Technical Competencies
• Knowledge of: Medical Devices Rules (MDR) 2017, CDSCO regulatory framework, State FDA requirements
• ISO 13485/ 9001, IVDR, US FDA regulations, MDSAP reqt, WHO registration processes
• Excellent understanding of regulatory documentation, product registration dossiers & technical files.
• Knowledge of EHS standards including ISO 14001, ISO 45001 & OSHA.

Preferred Qualifications

• Knowledge of Gujarati language.
• Experience managing regulatory inspections and audits.
• Exposure to multinational regulatory environments / Handled Exports of Local Products to US/Europe/MEA/SEA
• Diversity candidates are encouraged to apply.
• Demonstrated track record of maintaining strong compliance culture and ethical business practices.
• Reports To: Plant Manager

Employment Type: Full-Time | On-Site | Vadodara, Gujarat

Preferred Industry Background: Medical Devices, In-Vitro Diagnostics (IVD), Manufacturing, Life Sciences.