Location: Bengaluru | Full-Time | On-Site

Division: Regulatory & Quality Affairs

Industry: Medical Devices | IVD | Diagnostics

NeoDx is looking for a detail-oriented and motivated Regulatory Affairs Executive to support regulatory compliance and product registration activities across our diagnostics portfolio.

Key Responsibilities:

- Support regulatory pathways and product registrations for medical devices and IVD products.
- Prepare and review regulatory documentation as per CDSCO, EU IVDR, ISO, CLSI and other applicable requirements.
- Support submissions through CDSCO, NSWS, EU IVDR and other regulatory portals.
- Coordinate with regulatory authorities, internal teams, clinical partners and global stakeholders.
- Support ISO 14971 risk management, labeling, packaging, kit inserts and promotional material reviews.
- Support PMS, complaint handling, recalls and FSCA activities.
- Track regulatory submissions, renewals, approvals and query responses.
- Support audits, inspections, design transfer and regulatory compliance activities.
- Stay updated on regulatory guidelines, standards and industry practices.





Qualification:

Bachelor’s/Master’s in Biotechnology, Life Sciences, Microbiology or Biological Sciences.

Experience:

2–4 years of experience in Regulatory Affairs, Quality or related medical device/IVD/healthcare industries.

Preferred Skills:

Strong knowledge of CDSCO regulations and regulatory submissions

Experience with ISO 13485 audits

Experience supporting CDSCO visits, audits & inspections

ISO 13485 Internal Auditor Certification preferred

Strong documentation and communication skills

Ability to coordinate with global teams across time zones

Proficiency in Google Sheets

Candidates with a solid interest in Regulatory Affairs are encouraged to apply.

How to Apply:

- Google Form : https://forms.gle/9ecyR9ZLa66bTVWF6
- If any queries kindly write us at [email protected]
- For more information about our company and products, please visit www.neodx.in

Benefits:

- Food provided
- Health insurance

Work Location: In person

📌 Regulatory Affairs Executive (India)
🏢 NeoDx Biotech Labs
📍 India