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 10+ 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.