ELEXES Medical Consulting Pvt. Ltd. is hiring for the position of Project Associate – Medical Device Regulatory Consulting (RA/QA). Fresh graduates are encouraged to apply for this full-time opportunity. Candidates with a B.E./B.Tech. in Biomedical Engineering or a degree in a relevant discipline can apply.
The role involves supporting global medical device regulatory submissions, technical documentation, regulatory research, and quality management system documentation.
Job Details
| Particulars | Details |
|---|---|
| Company | ELEXES Medical Consulting Pvt. Ltd. |
| Job Title | Project Associate – RA/QA |
| Domain | Medical Device Regulatory Consulting |
| Job Type | Full-time |
| Experience | 0–1 year |
| Qualification | B.E./B.Tech. in Biomedical Engineering or a degree in a relevant discipline |
| Salary | Competitive CTC |
| Application Email | lisa@elexes.com / hr@elexes.com |
Position
Project Associate – Medical Device Regulatory Consulting (RA/QA)
The selected candidate will support regulatory submissions and documentation for global markets, including technical files, regulatory deliverables, and post-market surveillance documentation.
Key Responsibilities
- Support regulatory submissions and submission-related documentation for key global markets.
- Draft and review technical documentation, Design History Files (DHF), General Safety and Performance Requirements (GSPR) checklists, and technical files.
- Conduct regulatory research using regulations, guidance documents, standards, and regulatory authority sources.
- Support Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS) documentation, Periodic Safety Update Reports (PSURs), and other regulatory deliverables.
- Assist with global regulatory submission activities and client correspondence.
- Maintain project and technical documentation in accordance with the company’s Quality Management System (QMS).
Eligibility and Qualifications
Candidates applying for the Project Associate – RA/QA position should meet the following requirements:
- B.E./B.Tech. in Biomedical Engineering or a degree in a relevant discipline.
- Experience of 0–1 year.
- Fresh graduates are encouraged to apply.
- Willingness to learn international medical device and In Vitro Diagnostics (IVD) regulatory frameworks.
Required Skills
ELEXES Medical Consulting is looking for candidates with the following skills and attributes:
- Excellent written and verbal communication skills.
- Strong organizational skills and attention to detail.
- Good documentation discipline.
- Proactive attitude and intellectual curiosity.
- Learning agility and perseverance.
- Ability to work in a fast-paced, project-driven, multicultural environment.
How to Apply
Interested candidates can send their profiles or resumes to either of the following email addresses:
- Email 1: lisa@elexes.com
- Email 2: hr@elexes.com