Regulatory Affairs Specialist- Software Documentation(IEC)
Wrig Nanosystems
- Location
- Kasauli Tehsil, Himachal Pradesh, India
- Job type
- Full-time
Required skills
- biotechnology
- communication skills
- compliance
About the role
Wrig Nanosystems
Website:
truehb.com
Job details:
Key Responsibilities:
- Prepare, review, and maintain software-related regulatory documentation for medical devices.
- Ensure compliance with international regulatory standards including IEC standards, US FDA, EU MDR, and ISO 13485.
- Support preparation and maintenance of Technical Files / Design Dossiers as per regulatory requirements.
- Coordinate documentation for software lifecycle processes and validation.
- Assist in preparation of documents required for regulatory submissions in global markets.
- Maintain Design History Files (DHF), Device Master Records (DMR), and other quality system documentation.
- Work closely with R&D, Quality, and Product teams to ensure regulatory compliance during product development.
- Support internal and external audits, regulatory inspections, and compliance activities.
- Track updates in international medical device regulations and ensure documentation alignment.
Required Qualifications:
- Bachelor’s or Master’s degree in Biomedical Engineering, Biotechnology,B.Pharma
- 1–4 years of experience in Regulatory Affairs or Quality documentation for medical devices.
- Experience in software documentation for medical devices will be preferred.
- Knowledge of IEC standards, US FDA regulations, EU MDR, and ISO 13485 QMS.
- Familiarity with medical device regulatory submission processes.
- Strong documentation, analytical, and communication skills.
Click on Apply to know more.
This page is fully interactive when JavaScript is enabled. Please enable JavaScript to apply or browse related roles.