Siora Surgicals Pvt. Ltd., a leading manufacturer of orthopedic implants and instruments, is hiring a Regulatory Affairs Associate to ensure compliance with global medical device regulations.
Key Responsibilities:
- Prepare and submit regulatory filings (510(k), CE Marking, EU MDR 2017/745, US FDA, Indian MDR 2017).
- Develop Clinical Evaluation Reports (CER) including literature reviews and clinical data analysis.
- Conduct risk management (ISO 14971) and implement mitigation strategies.
- Oversee Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) studies.
- Ensure compliance with US FDA, EU MDR, Indian MDR, and ISO 13485 standards.
- Collaborate with cross-functional teams for regulatory documentation.
Desired Candidate Profile:
- Education: B.Tech (Mechanical/Medical Science), BSc, MSc.
- Experience: 3-4 years in medical device regulatory affairs.
- Skills: Regulatory submissions, CER, risk management, PMS, PMCF, compliance.
- Strong technical writing and communication skills.
About Siora Surgicals Pvt. Ltd.
Founded in 1987, Siora Surgicals is a leading manufacturer of orthopedic implants and instruments with a manufacturing unit in Rai, Sonipat (Haryana) and a corporate office in New Delhi. The company is known for its high-quality medical devices and compliance with global regulatory standards.
How to Apply?
Send your resume to: itsnitesh6721001@gmail.com
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