Regulatory Affairs Specialist

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 strong 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

Work arrangement
No