Wrig Nanosystems is hiring a Regulatory Affairs Specialist – Software Documentation (IEC) for its medical device division in Himachal Pradesh. This role is ideal for candidates with 1–4 years of experience in regulatory affairs, medical device documentation, and IEC standards compliance.

If you have expertise in US FDA, EU MDR, ISO 13485, and software lifecycle documentation, this opportunity offers strong exposure to global regulatory frameworks and product development compliance.

🔍 Job Overview

• Company: Wrig Nanosystems
• Role: Regulatory Affairs Specialist – Software Documentation (IEC)
• Location: Kasauli Tehsil, Himachal Pradesh, India
• Job Type: Full-time, On-site
• Experience: 1–4 Years
• Qualification: B.Pharm / Biotechnology / Biomedical Engineering
• Application Mode: Email

📌 Key Responsibilities

• Prepare, review, and maintain software regulatory documentation for medical devices
• Ensure compliance with IEC standards, US FDA, EU MDR, and ISO 13485 QMS
• Support preparation of Technical Files and Design Dossiers
• Maintain Design History Files (DHF) and Device Master Records (DMR)
• Coordinate software lifecycle documentation and validation activities
• Assist in global regulatory submissions
• Collaborate with R&D, Quality, and Product teams
• Support audits, inspections, and compliance activities
• Track and implement updates in international regulatory requirements

🎓 Qualifications & Skills

• Bachelor’s or Master’s degree in:
  • Biomedical Engineering
  • Biotechnology
  • B.Pharm
• Experience:
  • 1–4 years in Regulatory Affairs / Quality documentation
  • Exposure to medical device software documentation (preferred)
• Technical Knowledge:
  • IEC standards (critical for software medical devices)
  • US FDA regulations
  • EU MDR compliance
  • ISO 13485 Quality Management Systems
• Strong documentation, analytical, and communication skills

💼 Benefits & Career Growth

• Work on global medical device regulatory projects
• Exposure to software compliance & IEC standards (high-demand niche)
• Hands-on experience with DHF, DMR, and Technical Documentation
• Collaboration with cross-functional teams (R&D + QA + Regulatory)
• Strong career path in Medical Device Regulatory Affairs & Software Compliance

📩 How to Apply

Interested candidates can apply by sending their updated resume to:

📧 anchal.sharma@wrig.in

Application Link