Wrig Nanosystems Pvt. Ltd., an emerging medical device and bioelectronics company, is currently hiring Regulatory Affairs professionals for two exciting roles in India. The company is focused on developing advanced bioelectronics solutions and personalized diagnostics technologies.
Candidates with Biomedical Engineering, Biotechnology, Life Sciences, Electronics, or related degrees can apply. These roles provide strong exposure to medical device regulatory compliance, ISO standards, CDSCO submissions, EU MDR documentation, and software lifecycle documentation.
This is an excellent opportunity for freshers and early-career professionals interested in Regulatory Affairs, Medical Device Compliance, and Global Regulatory Documentation.
Available Roles
1. Regulatory Affairs Executive (0–2 Years)
📍 Location: Parwanoo, Himachal Pradesh
🏢 Company: Wrig Nanosystems Pvt. Ltd.
🎓 Experience: Freshers / 0–2 years
2. Regulatory Affairs Specialist – Software Documentation
📍 Location: New Delhi, India
🏢 Company: Wrig Nanosystems Pvt. Ltd.
🎓 Experience: 1–4 years
Both positions involve working closely with R&D, Quality Assurance, and Software teams to ensure regulatory compliance in medical device development.
Key Responsibilities
Selected candidates will work on regulatory documentation and compliance for medical devices.
Major responsibilities include:
- Prepare and maintain regulatory documentation for medical device software and hardware
- Support Indian MDR 2017 and CDSCO regulatory submissions
- Ensure compliance with EU MDR, US FDA regulations, and ISO 13485 quality management systems
- Assist with ISO 14971 risk management documentation
- Develop Design History Files (DHF) and Device Master Records (DMR)
- Prepare risk files, verification & validation (V&V) documentation
- Maintain traceability matrix and technical documentation
- Support software lifecycle documentation (IEC 62304)
- Assist during regulatory inspections and audits
- Track updates in international medical device regulations
Eligibility Criteria
Candidates must meet the following requirements:
Educational Qualification
- Bachelor’s or Master’s degree in:
- Biomedical Engineering
- Biotechnology
- Life Sciences
- Electronics
- Related disciplines
Experience
- Regulatory Affairs Executive: 0–2 years
- Regulatory Affairs Specialist: 1–4 years
Required Skills
- Strong technical documentation skills
- Knowledge of medical device regulations
- Familiarity with:
- ISO 13485
- ISO 14971
- EU MDR
- US FDA medical device regulations
- IEC 62304 software lifecycle
Freshers with strong regulatory documentation skills are encouraged to apply.
Why Join Wrig Nanosystems?
Working at Wrig Nanosystems provides an opportunity to build a career in medical device regulatory affairs and compliance.
Benefits include:
- Exposure to global medical device regulations
- Experience in CDSCO and EU MDR regulatory submissions
- Work with innovative bioelectronics and diagnostics technology
- Collaboration with R&D and product development teams
- Career growth in medical device regulatory affairs
How to Apply
Interested candidates can apply by sending their resume to:
You may also connect with the recruiter on LinkedIn if applying through the job portal.
Immediate joiners are preferred.