ELEXES Medical Consulting Pvt. Ltd. is hiring for the position of Project Associate – RA/QA (Medical Device Regulatory Consulting). This is a Work From Home job opportunity open to freshers and recent graduates, making it a relevant opportunity for candidates looking to begin their career in Medical Device Regulatory Affairs (RA), Quality Assurance (QA), and IVD regulatory consulting.
The role offers exposure to international medical device and IVD regulations, regulatory submissions, technical documentation, quality systems, and regulatory consulting projects.
Job Details
| Particular | Details |
|---|---|
| Company | ELEXES Medical Consulting Pvt. Ltd. |
| Position | Project Associate – RA/QA |
| Department | Medical Device Regulatory Consulting |
| Experience | 0–1 year |
| Qualification | B.E./B.Tech. in Biomedical Engineering or relevant discipline |
| Job Type | Full-Time |
| Work Mode | 100% Work From Home |
| Location | Remote / Work From Home |
| Experience Level | Freshers & Recent Graduates |
| Salary | Competitive CTC |
| Working Days | Monday to Friday |
| Weekends | Saturday & Sunday Off |
ELEXES Medical Consulting Project Associate RA/QA Job
The Project Associate – RA/QA will support regulatory consulting activities for medical devices and in-vitro diagnostic (IVD) products across global markets.
The position involves working with regulatory requirements, technical documentation, regulatory research, quality documentation, and client-related project activities. Candidates will have an opportunity to develop specialised knowledge of international Medical Device and IVD Regulatory Affairs while working remotely.
Key Responsibilities
Selected candidates will be responsible for supporting regulatory and quality-related project activities, including:
- Supporting regulatory submissions and associated documentation for global markets.
- Drafting and reviewing technical documentation.
- Supporting preparation and maintenance of Design History Files (DHF).
- Preparing and reviewing GSPR checklists and technical files.
- Conducting regulatory research using applicable regulations, guidance documents, and standards.
- Supporting Clinical Evaluation Reports (CERs).
- Assisting with Post-Market Surveillance (PMS) documentation.
- Supporting preparation of Periodic Safety Update Reports (PSURs) and other regulatory deliverables.
- Assisting with global medical device regulatory submissions.
- Supporting client communication and project coordination.
- Maintaining project and technical documentation according to the ELEXES Quality Management System (QMS).
Eligibility Criteria
Candidates applying for the ELEXES Project Associate – RA/QA position should meet the following requirements:
Educational Qualification
- B.E. or B.Tech. in Biomedical Engineering or a relevant discipline.
- Fresh graduates are encouraged to apply.
Experience
- 0–1 year of experience.
- Candidates without prior industry experience may apply if they meet the educational and skill requirements.
Desired Skills
ELEXES is looking for candidates with:
- Strong written and verbal communication skills.
- Excellent organisational skills.
- Strong attention to detail.
- A proactive and curious approach to learning.
- Willingness to develop regulatory and quality expertise.
- Ability to work effectively in a fast-paced, project-driven environment.
- Interest in international Medical Device and IVD regulatory frameworks.
Benefits of Working at ELEXES
The company highlights several benefits associated with this opportunity:
- 100% Work From Home
- Freshers and recent graduates can apply
- Health insurance
- Saturday and Sunday off
- Full-time employment
- Learning and professional development opportunities
- Exposure to global medical device regulations
- Exposure to IVD regulatory frameworks
- Opportunity to work on international regulatory consulting projects
- Scope to develop specialised Medical Device Regulatory Affairs and Quality Assurance expertise
Career Opportunity in Medical Device Regulatory Affairs
Medical Device Regulatory Affairs is a specialised career area involving regulatory submissions, technical documentation, standards, quality systems, clinical evaluation, and post-market regulatory activities.
For biomedical engineering graduates, an entry-level regulatory consulting position can provide exposure to several areas of the medical device lifecycle. The ELEXES role specifically mentions work involving technical files, DHF, GSPR checklists, CERs, PMS documentation, PSURs, global regulatory submissions, and QMS documentation.
Candidates interested in building a long-term career in medical device regulatory consulting may therefore find the role relevant to their professional interests.
How to Apply for ELEXES Project Associate RA/QA Job
Interested and eligible candidates can apply by sending their updated CV/profile to the following email addresses:
Email: lisa@elexes.com
Email: hr@elexes.com