Senior Manager- Regulatory and Quality Assurance

Swear Healthcare is a leading manufacturer of surgical and examination latex gloves, with a manufacturing facility based in Dholpur, Rajasthan,  and a corporate office in Gurugram. We are rapidly expanding and looking  for a qualified Regulatory and Quality Assurance Manager to join our  Team in Dholpur, Rajasthan.

What You’ll Do:

• Compile, review & implement Quality Management System (QMS) guidelines for ISO 13485:2016 certification.
• Implement Indian Medical Device Rules (IMDR) 2017 to obtain MD-5 Manufacturing License, Neutral Code, Non-conviction Certificate, Marketing Standing Certificate & QMS Certificate. Coordinate with Central & State Drugs Control Authorities for licenses under IMDR 2017.
• Liaise with State Health Department for Wholesale Licenses & tender-related inspections.
• Coordinate with Notified Bodies for ISO 13485, CE MDR audits, BIS-ISI yearly inspections & other external audits.
• Manage EUDAMED Portal, including actor registration & Basic UDI/DI registration.
• Ensure compliance with UDI labelling requirements (GS1, ISO 15223-1, ISO 20417, EN 1041 & EU MDR 2017/745).
• Design, approve & maintain compliant product labels in accordance with ISO standards & customer requirements.
• Compile, update & maintain CE Technical Files & EU MDR 2017/745 Technical Files.
• Coordinate with the EU Representative to meet MDR 2017/745 requirements.
• Prepare & manage Risk Management Files (EN ISO 14971:2019).
• Coordinate with external labs for testing (Physical, Performance, Biocompatibility, etc.).
• Collect & analyse clinical feedback via PMS/PMCF activities.
• Implement traceability systems from raw material to finished product.
• Prepare CAPA for complaints & process improvements.
• Conduct supplier audits & manage supplier qualification to ensure product safety & quality.
• Oversee QA activities to strengthen QMS & GMP compliance.
• Conduct in-house staff training on GMP, ISO 13485 & QMS requirements.
• Coordinate with sales teams for product technical queries.
• Support in-house lab with routine testing jobs.
• Conduct process validations: dipping, packaging, storage, transport & EtO sterilisation.
• Knowledge of barcode symbology & GS1 barcodes for labelling compliance.

What We’re Looking For:

• Must be from the medical device industry (glove industry preferred).
• Strong teamwork skills.

Interested or know someone who fits the bill?

Send your CV to jobs@swearhealthcare.com