Job Summary

S H Pitkar Orthotools Pvt. Ltd. is looking for an experienced
Regulatory Affairs Executive
to support regulatory compliance activities for medical devices. The ideal candidate should have hands-on experience in preparing regulatory documentation and a sound understanding of international and Indian medical device regulations.

Qualification
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Medical Devices, Biomedical Engineering, Biotechnology, or any relevant Science discipline.

Key Responsibilities
- Prepare and maintain
Technical Files
and
Device Master Files (DMF)
.
- Ensure compliance with
ISO 13485
,
EU MDR (2017/745)
,
CDSCO (MDR 2017)
, and
ISO 14971
(Risk Management).
- Prepare, review, and maintain regulatory documentation.




- Support product registration and regulatory submissions.
- Coordinate with cross-functional teams for design, quality, production, and documentation activities.
- Participate in internal and external audits.
- Maintain Design History Files (DHF), risk management documents, and regulatory records.
- Track changes in regulatory requirements and ensure ongoing compliance.
- Support regulatory inspections and customer audits.

Location:
Talegaon Dabhade, Pune

Company:
S H Pitkar Orthotools Pvt. Ltd.

Experience:
3–5 Years

Immediate Joiners will be given preference.
- Apply Now:
[email protected]

📌 Regulatory Affairs Executive (Mawal)
🏢 S.H.Pitkar Orthotools
📍 Mawal