Job Opportunity: Regulatory Affairs Specialist – Software Documentation (IEC)
Job Summary
Wrig Nanosystems is seeking a detail-oriented and experienced Regulatory Affairs Specialist to join our medical device division in Kasauli, Himachal Pradesh. This is an on-site, full-time position ideal for professionals with 1–4 years of experience in regulatory affairs and medical device documentation. The successful candidate will play a critical role in ensuring our software-integrated medical devices meet global regulatory requirements, including US FDA, EU MDR, and IEC software standards. If you are passionate about medical technology and navigating the complex intersection of software lifecycle management and regulatory compliance, we invite you to apply.
Role Overview
- Company: Wrig Nanosystems
- Role: Regulatory Affairs Specialist – Software Documentation (IEC)
- Location: Kasauli Tehsil, Himachal Pradesh, India
- Job Type: Full-time, On-site
- Experience Level: 1–4 Years
- Education: B.Pharm, Biotechnology, or Biomedical Engineering
Key Responsibilities
As a Regulatory Affairs Specialist, you will be responsible for maintaining the integrity of our regulatory documentation and ensuring our products adhere to international safety and quality benchmarks. Your daily responsibilities will include:
- Documentation Management: Prepare, review, and maintain comprehensive software regulatory documentation, ensuring all records are accurate and up-to-date.
- Regulatory Compliance: Ensure all medical device processes align with IEC standards, US FDA regulations, EU MDR, and ISO 13485 Quality Management Systems.
- Technical Dossiers: Support the development and maintenance of Technical Files, Design Dossiers, Design History Files (DHF), and Device Master Records (DMR).
- Software Lifecycle: Coordinate software lifecycle documentation and validation activities, ensuring that every stage of software development meets rigorous regulatory expectations.
- Submissions & Audits: Assist in the preparation of global regulatory submissions and provide support during external audits, internal inspections, and compliance reviews.
- Cross-functional Collaboration: Work closely with the R&D, Quality Assurance, and Product teams to ensure compliance is integrated into the product design and development cycle.
- Regulatory Intelligence: Track and interpret updates in international regulatory requirements to ensure the organization remains ahead of changing standards.
Requirements
We are looking for candidates who combine technical knowledge with strong analytical and communication skills:
- Education: A Bachelor’s or Master’s degree in Biomedical Engineering, Biotechnology, or Pharmacy (B.Pharm).
- Experience: 1–4 years of experience in a regulatory affairs or quality documentation role within the medical device industry. Prior exposure to software documentation is highly preferred.
- Technical Proficiency: A solid understanding of IEC standards (particularly regarding software in medical devices), US FDA requirements, EU MDR, and ISO 13485 QMS.
- Skills: Exceptional attention to detail, strong organizational skills, and the ability to articulate complex regulatory concepts to cross-functional team members.
Benefits & Career Growth
Joining Wrig Nanosystems offers a unique opportunity to advance your career in a high-demand sector of the healthcare industry:
- Global Exposure: Work on international regulatory projects that impact the medical device market on a global scale.
- Niche Expertise: Gain deep, specialized experience in software compliance and IEC standards, which are critical assets in the modern medical device landscape.
- Professional Development: Receive hands-on experience in managing DHF, DMR, and technical documentation—the backbone of regulatory success.
- Collaborative Environment: Grow your career by working at the intersection of R&D, Quality, and Regulatory departments, gaining a holistic view of the medical device product lifecycle.
How to Apply
If you meet the requirements and are interested in contributing to our mission, we would love to hear from you. Please submit your updated resume via email to:
Email Address: [email protected]
Please ensure your subject line clearly states your name and the position you are applying for. We look forward to reviewing your application.