Wrig Nanosystems, a rapidly growing medical diagnostics and healthcare technology company, has announced an exciting opportunity for the position of Regulatory Affairs Executive at its facility in Parwanoo, Himachal Pradesh. Candidates with backgrounds in Biomedical Engineering, Biotechnology, Medical Devices, Life Sciences, or related disciplines are encouraged to apply.
This Regulatory Affairs Executive job in Himachal Pradesh is ideal for freshers and professionals with up to 2 years of experience who want to build a career in medical device regulatory affairs, CDSCO compliance, ISO 13485 quality systems, and MDR documentation.
About Wrig Nanosystems
Wrig Nanosystems is focused on developing next-generation diagnostic technologies and innovative healthcare solutions. The company works in the medical devices and in-vitro diagnostics (IVD) sector, ensuring regulatory compliance and quality standards while bringing cutting-edge products to market.
Job Details
| Particulars | Details |
|---|---|
| Position | Regulatory Affairs Executive |
| Company | Wrig Nanosystems |
| Location | Parwanoo, Himachal Pradesh, India |
| Job Type | Full-Time |
| Experience | 0-2 Years |
| Industry | Medical Devices / IVD |
| Mode | On-Site |
Key Responsibilities
The selected candidate will be responsible for:
- Supporting regulatory compliance activities related to CDSCO, MDR, IVDR, and international regulations.
- Preparing and maintaining technical documentation including DHF, DMF, PMF, and V&V reports.
- Assisting in ISO 13485 quality management system compliance.
- Supporting risk management activities as per ISO 14971 requirements.
- Maintaining software validation documentation and traceability records.
- Coordinating with Research & Development, Quality Assurance, and cross-functional teams.
- Supporting regulatory submissions and documentation updates for medical devices and IVD products.
Required Qualifications
Candidates should possess:
- Bachelor’s or Master’s degree in:
- Biomedical Engineering
- Biotechnology
- Life Sciences
- Medical Devices
- Engineering or related disciplines
Preferred Knowledge
- Medical Devices and IVD regulations
- Regulatory Affairs processes
- CDSCO regulations
- European MDR and IVDR
- ISO 13485 Quality Management Systems
- ISO 14971 Risk Management
- Technical Documentation Preparation
- Software Validation
- IEC 62304 (Preferred)
Skills Required
- Strong documentation skills
- Analytical thinking
- Regulatory compliance understanding
- Technical writing abilities
- Cross-functional collaboration
- Attention to detail
- Problem-solving skills
Why Join Wrig Nanosystems?
- Opportunity to work in the growing medical device and diagnostics industry.
- Exposure to global regulatory standards and compliance frameworks.
- Hands-on experience with CDSCO, MDR, IVDR, and ISO 13485.
- Collaborative work environment with R&D and quality teams.
- Career growth opportunities in regulatory affairs and quality assurance.
Salary Expectations
Based on industry benchmarks for Regulatory Affairs Executive roles in medical device companies, the expected salary range is:
₹3.0 LPA – ₹5.5 LPA
Actual compensation may vary depending on qualifications, skills, and experience.
How to Apply
Interested candidates can apply directly by sending their updated resume to:
Email: diksha.kashyap@wrig.in
Applicants should mention “Application for Regulatory Affairs Executive” in the subject line of their email.