Are you a Biomedical Engineering or Life Sciences graduate ready to step into the high-growth world of medical devices and bioelectronics? A promising opportunity is now open at Wrig Nanosystems Pvt. Ltd. for the position of Regulatory Affairs Executive in Parwanoo, Himachal Pradesh.
Whether you’re a fresher or have up to 2 years of experience, this role offers hands-on exposure to global regulatory systems and cutting-edge diagnostic innovation.
🏥 About Wrig Nanosystems
Wrig Nanosystems is a next-generation medical device and bioelectronics company developing smart diagnostic technologies. Their focus lies in integrating advanced electronics with biological systems to create personalized healthcare solutions.
Working here means contributing to technologies that could redefine early disease detection and patient monitoring.
🛠️ Role Overview: Regulatory Affairs Executive
In medical devices, Regulatory Affairs (RA) ensures that every product launched is safe, compliant, and legally approved for sale. This is not just documentation — it’s a strategic and globally relevant career path.
🔎 Key Responsibilities
1️⃣ Global Regulatory Compliance
- Support submissions to Central Drugs Standard Control Organisation (CDSCO) under Indian Medical Device Rules (MDR) 2017
- Assist in compliance with EU MDR (European Medical Device Regulation) for exports 🇮🇳🇪🇺
2️⃣ Quality Management Systems (QMS)
- Maintain documentation aligned with:
- ISO 13485 – Quality Management Systems for Medical Devices
- ISO 14971 – Risk Management for Medical Devices
3️⃣ Technical Documentation
- Prepare:
- Design History File (DHF)
- Risk Management Files
- Traceability Matrix
- Maintain structured documentation throughout the device lifecycle
4️⃣ Verification & Validation (V&V)
- Support preparation of V&V protocols and reports
- Ensure device meets intended use and performance requirements
5️⃣ Software Compliance (Bioelectronics Focus)
- Assist in documentation aligned with:
- IEC 62304 – Software lifecycle processes
- Prepare:
- Software Requirement Specifications (SRS)
- Software Validation Test Plans 💻📊
✅ Eligibility Criteria
Education:
- Bachelor’s degree in Biomedical Engineering, Electronics, Life Sciences, or related technical field
Experience:
- 0–2 years (Freshers strongly encouraged) 🎓
Skills Required:
- Strong technical writing
- High attention to detail
- Understanding of compliance frameworks
Preference:
- Immediate joiners
- Candidates willing to relocate to Parwanoo
📍 Why Parwanoo?
Parwanoo is located at the gateway to Himachal Pradesh. It offers:
- Industrial infrastructure
- Clean environment
- Scenic hill surroundings 🏔️🌲
- Balanced professional and personal life
For someone beginning their career, it provides focus without big-city distractions — ideal for skill development.
💼 Why Choose Medical Device Regulatory Affairs?
As someone building a career in healthcare writing and regulatory domains (which aligns well with your content writing background), RA is:
- 📈 High-growth globally
- 🌍 Internationally transferable
- 💰 Well-compensated long-term
- 🔒 Stable and compliance-driven
Mastering standards like ISO 13485 and IEC 62304 early makes you a globally valuable professional.
📧 How to Apply
Step 1: Prepare a professional resume highlighting:
- Academic projects
- Documentation experience
- Any regulatory exposure
Step 2: Draft a short, impactful cover email.
Step 3: Send your application to:
📩 anchal.sharma@wrig.in
Suggested Email Subject:Application for RA Executive – [Your Name] – Biomedical Graduate
