Freshers Needed In Project Associate – Medical Device Regulatory Consulting At ELEXES Medical

ELEXES Medical Consulting Pvt Ltd. is hiring a Project Associate – Medical Device Regulatory Consulting to join its growing technical team. This is an excellent opportunity for fresh Biomedical Engineering graduates and candidates with 0–1 year of experience who want to build a career in medical device regulatory affairs, IVD regulations, regulatory submissions, technical documentation, and global regulatory consulting.

The selected candidate will support regulatory projects for international markets and gain exposure to technical documentation, regulatory research, Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSURs), DHF documentation, GSPR checklists, and global medical device submission activities.

If you are looking for Medical Device Regulatory Affairs jobs for freshers, this ELEXES Medical Consulting opportunity could be an ideal starting point.

Job Details

Key Responsibilities

As a Project Associate – Medical Device Regulatory Consulting, you will support the technical and regulatory consulting team in a variety of global medical device and IVD regulatory activities.

Key responsibilities include:

• Support regulatory submissions and submission-related documentation for key global markets.
• Draft and review medical device technical documentation and technical files.
• Assist with Design History File (DHF) documentation.
• Support the preparation and review of GSPR checklists.
• Conduct regulatory research using applicable regulations, guidance documents, international standards, and regulatory authority sources.
• Support the preparation of Clinical Evaluation Reports (CERs).
• Assist with Post-Market Surveillance (PMS) documentation.
• Support the development of Periodic Safety Update Reports (PSURs) and other regulatory deliverables.
• Assist with global regulatory submission activities.
• Support client correspondence related to regulatory projects.
• Maintain project and technical documentation in accordance with the ELEXES Quality Management System (QMS).
• Learn and develop expertise in international medical device and IVD regulatory frameworks.

Qualifications and Eligibility Criteria

Candidates applying for this Medical Device Regulatory Consulting job should meet the following requirements:

• B.E. or B.Tech in Biomedical Engineering.
• Candidates with a degree in another relevant discipline may also be considered.
• 0–1 year of experience in a relevant field.
• Fresh graduates with a strong interest in medical device regulatory affairs are encouraged to apply.
• Excellent written and verbal communication skills.
• Strong organisational and documentation skills.
• High attention to detail and strong document discipline.
• Proactive attitude and willingness to learn.
• Intellectual curiosity and learning agility.
• Ability to work effectively in a fast-paced, project-driven environment.
• Ability to collaborate in a multicultural work environment.
• Interest in learning international medical device and IVD regulations.

Skills That Can Help You Succeed

Candidates interested in building a career in medical device regulatory affairs may benefit from knowledge or interest in:

• Medical Device Regulations
• IVD Regulatory Affairs
• Regulatory Submissions
• Technical Documentation
• Design History File (DHF)
• General Safety and Performance Requirements (GSPR)
• Clinical Evaluation Reports (CER)
• Post-Market Surveillance (PMS)
• Periodic Safety Update Reports (PSUR)
• Quality Management Systems (QMS)
• International Regulatory Standards
• Regulatory Research

Freshers are encouraged to apply even if they do not have professional experience in all these areas.

Why Join ELEXES Medical Consulting?

Joining ELEXES Medical Consulting provides an opportunity to develop practical expertise in the rapidly growing field of medical device and IVD regulatory consulting.

The role offers exposure to:

• Global medical device regulatory requirements.
• International regulatory submission processes.
• Technical and regulatory documentation.
• Medical device and IVD regulatory frameworks.
• Client-based consulting projects.
• Structured technical documentation practices.
• Progressive career opportunities within the organization.

This position can be particularly valuable for Biomedical Engineering graduates seeking to begin a long-term career in Medical Device Regulatory Affairs.

How to Apply?

Interested and eligible candidates can send their updated profile or resume via email.

📧 Email: lisa@elexes.com
📧 Email: hr@elexes.com