Axio Biosolutions is seeking a highly motivated Regulatory Affairs Intern to assist with EU MDR and US FDA documentation and compliance for medical devices. This is an excellent opportunity for freshers to gain hands-on experience in regulatory submissions, quality assurance, and compliance processes.
Job Description: Regulatory Affairs Intern
Key Responsibilities:
- Assist in preparing and reviewing regulatory documents for EU MDR & US FDA submissions.
- Support in compiling technical documentation, including Design Dossiers, Technical Files, and STED submissions.
- Conduct gap assessments to ensure compliance with regulatory standards.
- Collaborate with cross-functional teams (R&D, Quality Assurance, Clinical) for regulatory requirements.
- Stay updated with evolving medical device regulations (MDR, FDA, ISO 13485).
- Assist in audits and regulatory inspections as needed.
Eligibility Criteria:
- Master’s degree in Pharmacy, Biotechnology, Biomedical/Medical Engineering, or related fields.
- Strong communication, documentation, and analytical skills.
- Basic understanding of medical device regulations (EU MDR, FDA, ISO 13485) is a plus.
- Detail-oriented with the ability to manage multiple tasks efficiently.
About Axio Biosolutions
Axio Biosolutions is a leading medical technology company specializing in innovative hemostatic and wound care solutions. Known for its flagship product Axiostat®, the company is committed to advancing healthcare through cutting-edge medical devices.
Why Join Axio Biosolutions?
✅ Hands-on experience in EU MDR & FDA regulatory processes
✅ Mentorship from industry experts
✅ Potential for full-time employment based on performance
✅ Dynamic work environment in a fast-growing med-tech company
How to Apply?
Location: On-site – Axio Biosolutions Pvt. Ltd., Ahmedabad
Duration: 3 months (with potential for full-time conversion)
Stipend: Industry Standard
