If you’re looking to build a career in Medical Device Regulatory Affairs, here’s an excellent opportunity. Maven Profcon Services LLP is hiring a Junior Regulatory Executive โ EU MDR/IVDR for its Ahmedabad office. Candidates with at least 6 months of internship experience in EU MDR/IVDR Regulatory Affairs are encouraged to apply.
This Junior Regulatory Executive EU MDR job in Ahmedabad is ideal for pharmacy, life sciences, biomedical engineering, and related graduates seeking hands-on experience with EU MDR 2017/745, EU IVDR 2017/746, Technical Documentation, Risk Management, Clinical Evaluation, and CE Marking processes.
Junior Regulatory Executive โ EU MDR/IVDR Job Details
| Particular | Details |
|---|---|
| Position | Junior Regulatory Executive โ EU MDR/IVDR |
| Company | Maven Profcon Services LLP |
| Job Type | Full-Time |
| Location | Makarba, Ahmedabad, Gujarat |
| Experience | Minimum 6 months internship in EU MDR/IVDR Regulatory Affairs |
| Industry | Medical Device Regulatory Affairs |
| Qualification | Bachelor’s Degree in Pharmacy, Life Sciences, Biomedical Engineering or related discipline |
Key Responsibilities
The selected candidate will support regulatory compliance activities for medical devices and in-vitro diagnostics by:
- Assisting in preparation and maintenance of regulatory documentation under EU MDR 2017/745 and EU IVDR 2017/746
- Supporting technical documentation preparation and document control
- Assisting with Risk Management Files in accordance with regulatory requirements
- Supporting Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER)
- Conducting regulatory intelligence and compliance research
- Performing gap assessments under supervision
- Coordinating with cross-functional teams to collect technical documentation
- Supporting Notified Body submissions and responding to regulatory queries
- Assisting in preparation of US FDA 510(k) submission dossiers
- Monitoring updates in global medical device regulations
Required Qualifications
Applicants should possess:
- Bachelor’s degree in Pharmacy, Life Sciences, Biomedical Engineering, Biotechnology, or related discipline
- Minimum 6 months internship experience in Medical Device or IVD Regulatory Affairs
- Basic understanding of:
- EU MDR 2017/745
- EU IVDR 2017/746
- ISO 13485
- ISO 14971
- Knowledge of medical device regulatory documentation
- Strong organizational and documentation skills
- Good communication and teamwork abilities
- Passion for building a career in Regulatory Affairs
Preferred Skills
Candidates with knowledge of the following will have an advantage:
- CE Marking process
- Technical Documentation preparation
- Clinical Evaluation Reports (CER)
- Performance Evaluation Reports (PER)
- Risk Management
- Regulatory Intelligence
- FDA 510(k) documentation
- Medical Device Quality Management Systems
Why Join Maven Profcon Services LLP?
This opportunity allows candidates to:
- Gain practical experience in EU MDR Regulatory Affairs
- Work alongside experienced regulatory professionals
- Learn international medical device compliance requirements
- Develop expertise in CE Marking and Technical Documentation
- Build a long-term career in the rapidly growing Medical Device Regulatory Affairs industry
- Work on global regulatory projects
Who Should Apply?
This opportunity is suitable for:
- B.Pharm graduates
- M.Pharm graduates
- Biomedical Engineering graduates
- Biotechnology graduates
- Life Sciences graduates
- Freshers with at least six months of EU MDR/IVDR internship experience
- Candidates seeking Regulatory Affairs jobs in Ahmedabad
How to Apply
