Blueneem Medical Devices Pvt. Ltd. has announced an exciting opportunity for the position of Regulatory Affairs Executive in Bengaluru. Candidates with 1–2 years of experience in regulatory affairs within the medical devices industry are invited to apply.
This opportunity is ideal for professionals experienced in CDSCO registration, ISO 13485 documentation, Clinical Evaluation Reports (CER), Post-Approval Change (PAC) dossiers, and regulatory submissions for both Indian and international markets.
Job Overview
| Particular | Details |
|---|---|
| Company | Blueneem Medical Devices Pvt. Ltd. |
| Position | Regulatory Affairs Executive |
| Location | Bengaluru, Karnataka |
| Qualification | M.Pharm |
| Experience | 1–2 Years |
| Industry | Medical Devices |
| Job Type | Full-Time |
| Application Mode |
Key Responsibilities
Selected candidates will be responsible for:
- Preparing CDSCO registration documentation for Class B, Class C, and Class D medical devices.
- Managing product registrations, submissions, approvals, and renewals.
- Ensuring regulatory compliance for Indian as well as international markets.
- Responding to regulatory authority queries efficiently.
- Preparing and managing Free Sale Certificates (FSC) and Market Standing Certificates.
- Developing Post-Approval Change (PAC) dossiers.
- Preparing Clinical Evaluation Reports (CERs).
- Coordinating with cross-functional teams for regulatory submissions.
- Maintaining ISO 13485 Quality Management System (QMS) documentation and compliance.
Required Qualification
Candidates should possess:
- M.Pharm degree from a recognized university.
- 1–2 years of Regulatory Affairs experience in the Medical Devices industry.
- Good knowledge of:
- CDSCO Medical Device Regulations
- ISO 13485 Quality Management Systems
- Regulatory documentation
- Product registrations
- CER preparation
- PAC dossier preparation
- FSC documentation
Freshers are not eligible for this position.
Preferred Skills
- Strong documentation and technical writing abilities.
- Excellent communication and coordination skills.
- Knowledge of Indian Medical Device Rules (MDR).
- Regulatory submission planning and lifecycle management.
- Ability to work with multiple departments and regulatory authorities.
Why Join Blueneem Medical Devices?
Working with Blueneem Medical Devices provides professionals an opportunity to:
- Build expertise in Medical Devices Regulatory Affairs.
- Gain exposure to Indian and international regulatory submissions.
- Work on CDSCO registrations and compliance projects.
- Enhance experience in ISO 13485 Quality Management Systems.
- Develop skills in Clinical Evaluation Reports and Post-Approval Change documentation.
- Grow within a specialized and expanding medical devices organization.
How to Apply
Interested and eligible candidates can send their updated resume to:
