NeoDx
Website:
neodx.in
Job details:
We’re Hiring | Regulatory Affairs Executive
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 strong interest in Regulatory Affairs are encouraged to apply.
How to Apply:
- Google Form : https://forms.gle/9ecyR9ZLa66bTVWF6
- If any queries kindly write us at hr@neodx.in
- For more information about our company and products, please visit www.neodx.in
Click on Apply to know more.
