About Ace Osteomedica

Ace Osteomedica designs and manufactures advanced orthopedic and neuro implants — trauma systems, foot and ankle fixation, microplating and small bone implants, and cranial/spinal neuro implants — alongside custom implants built with surgeons for specific cases. We export across Latin America, the Middle East, Southeast Asia, and Europe, and exhibit at major industry events including.

The Role

We're hiring a Regulatory Affairs Specialist to own regulatory activity across our orthopedic and neuro implant portfolio — spanning multiple international markets, not a single regulatory regime. You'll prepare and maintain technical files and submissions, drive product registrations and renewals, and be the internal voice on what regulatory change means for engineering, QA, and marketing before it becomes a problem.

What you'll do
Prepare, review, and maintain regulatory documentation and technical files (CSDTs, DoCs, and equivalent) for multi-market submissions
Coordinate registrations and approvals across [e.g. CDSCO, MDR, ANVISA,



and other markets you file in]
Track regulatory and standards changes and translate them into concrete action for internal teams
Review labeling, promotional materials, and product information for compliance
Maintain audit-ready records and support inspections and audits
Flag process gaps and drive continuous improvement in regulatory workflows

What you bring
Bachelor's degree in biomedical engineering, life sciences, pharmacy, or a directly rela ted field - 4+ years in regulatory affairs or QA, ideally in medical devices — orthopedic or neuro implant experience is a solid plus
Working knowledge of MDR, FDA, and ISO 13485/14971 for medical devices
Sharp documentation and analytical skills — this role lives or dies on precision
Comfortable working cross-functionally with engineering, QA, and marketing

Nice to have
Experience filing in Latin American or Middle Eastern regulatory f rameworks

📌 Regulatory Affairs Specialist Ludhiana (India)
🏢 Ace Osteomedica
📍 India