Regulatory Affairs Professional

Siemens Healthineers; Vadodara; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Siemens Healthineers is seeking an experienced Regulatory Affairs professional to lead regulatory compliance for IVD manufacturing. You will manage licenses, registrations, and submissions with CDSCO/State FDA, and coordinate international filings while ensuring ISO 13485, MDR 2017, and related standards compliance.

The role requires a proactive, detail‑driven leader to support new product registrations, manufacturing licenses, and expansion efforts, liaising with government authorities and

Qualifications

• Bachelor's/Master's degree in Pharmacy/Life Sciences or related field.
• Minimum 10+ years RA experience in IVD manufacturing.
• Proven track record with CDSCO/State FDA and international submissions.

Responsibilities

• Prepare and submit manufacturing licenses for IVDs and related products.
• Act as primary liaison with CDSCO, State FDA, and authorities.
• Ensure compliance with MDR 2017, ISO 13485 and other regulatory requirements.

Skills

Regulatory affairs

Quality management

US FDA

CDSCO

MDSAP

ISO 13485

IVD

Education

Bachelor's in Pharmacy

Master’s in Life Sciences

Regulatory Affairs

Tools

CDSCO filings

Regulatory submissions

Job description

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.

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
• Demonstrated track record of maintaining strong compliance culture and ethical business practices.

Diversity candidates are encouraged to apply.

Reports To: Plant Manager

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

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