"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya"
"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya."
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(Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers) |
Introduction
If you are a fresher or early-career professional aiming to build a strong career in Medical Device Regulatory Affairs and Quality Assurance, this opportunity can be a perfect starting point.
ELEXES Medical Consulting Pvt. Ltd. has announced hiring for the position of Project Associate I – Regulatory Affairs & Quality Assurance (RA/QA).
This role is specially designed for fresh graduates and candidates with up to 6 months of experience who want hands-on exposure to global medical device regulations, including US FDA, EU MDR, CDSCO, Health Canada, along with ISO 13485 quality systems.
The position offers real project experience under expert mentorship, making it ideal for long-term growth in the medical device regulatory domain.
About The Company – ELEXES Medical Consulting Pvt. Ltd.
ELEXES Medical Consulting Pvt. Ltd. is a specialized regulatory and quality consulting organization serving global medical device manufacturers. The company focuses on delivering end-to-end regulatory affairs and quality assurance solutions aligned with international standards.
Company Name: ELEXES Medical Consulting Pvt. Ltd.
Headquarters: India (serving global clients)
Industry: Medical Device Regulatory & Quality Consulting
Nature: Private Limited Company
Established: As per available industry information, ELEXES has been operational for several years in the medical device consulting s.pace
Employees: Approx. 20–100 professionals (RA, QA, consultants & technical experts)
ELEXES is known for working closely with the US FDA, EU MDR, ISO 13485, ISO 14971, and other international frameworks, making it an excellent learning environment for aspiring RA/QA professionals.
Job Overview Summary
The Project Associate I – RA/QA role at ELEXES Medical Consulting provides practical exposure to real-world medical device regulatory and quality projects. Selected candidates will support global regulatory submissions, technical documentation, risk management activities, and quality system compliance.
This position allows freshers to understand the complete medical device lifecycle, from design controls to post-market surveillance, while working unthe der guidance of experienced RA/QA consultants.
Vacancy Details (Official)
Company Name: ELEXES Medical Consulting Pvt. Ltd.
Job Title: Project Associate I – Regulatory Affairs & Quality Assurance
Department: Regulatory Affairs / Quality Assurance
Job Type: Full-time
Experience Required: Freshers – 6 months
Work Mode: Work From Home (Flexible)
Industry: Medical Devices / Regulatory Consulting
Key Responsibilities – Explained
As a Project Associate I (RA/QA), your responsibilities will include:
Supporting preparation and compilation of global regulatory submissions such as US FDA 510(k), EU MDR Technical Files, C, DSC, O, and Health Canada
Assisting in development and maintenance of Design History Files (DHF) and GSPR checklists
Supporting design controls, risk management activities (FMEA, hazard analysis), and verification & validation documentation
Contributing to post-market surveillance activities, including CER, PMS reports, and PSURs
Assisting in drafting, revising, and maintaining SOPs, templates, and work instructions
Ensuring compliance with ISO 13485:2016 and internal quality systems
Supporting internal and external regulatory & quality audits
Collaborating with cross-functional teams and senior consultants
Participating in internal training and continuous learning programs
Eligibility Criteria (Official)
Candidates must hold a Bachelor’s or Master’s Degree in:
Biomedical Engineering
Medical Electronics
Biotechnology
(From AICTE / UGC recognized institutions)
Experience:
Freshers or candidates with up to 6 months experience
Additional Eligibility:
Electronics & Instrumentation or Mechanical Engineering graduates with medical device exposure may apply
Strong written and verbal English communication skills
Basic understanding of medical device development lifecycle
Skills Required
Ideal candidates should possess:
Basic understanding of medical device regulations
Awareness of US FDA, EU MDR, ISO 13485, ISO 14971
Interest in learning IEC 60601 and IEC 62304
Strong documentation and attention to detail
Analytical thinking and compliance mindset
Professional communication and teamwork skills
Willingness to learn and adapt to global standards
Salary Estimate
Estimated Salary Package:
₹3.0 LPA – ₹5.0 LPA (Indicative)
Actual salary may depend on:
Educational background
Regulatory knowledge
Interview performance
Project requirements
Interview Details (Official)
Interview Mode: Online (WFH-based role)
Selection Process:
Resume Screening
Technical Interview
HR Discussion
Only shortlisted candidates will be contacted.
Required Documents
Candidates should keep the following documents ready:
Updated Resume / CV
Educational Certificates & Transcripts
Internship / Project Certificates (if any)
Government ID Proof
Passport-size Photograph
Job Location
Work Mode: Work From Home (WFH)
Reporting Office: ELEXES Medical Consulting Pvt. Ltd. (India)
Apply Method
Interested candidates should email their resume to:
📌 Email Subject:
Project Associate I – RA/QA
FAQs – Project Associate I RA/QA Job
Q1. Is this job suitable for freshers?
Yes, fresh graduates are encouraged to apply.
Q2. Is this a work from home job?
Yes, flexible WFH options are available.
Q3. Will I get US FDA and EU MDR exposure?
Yes, the role includes real exposure to global regulatory submissions.
Q4. Is ISO 13485 experience provided?
Yes, candidates will work on 13485-compliantiant documentation.
Q5. Is prior experience mandatory?
No, candidates with 0–6 montof hs experience are eligible.
Final Conclusion
The Project Associate I – Regulatory Affairs & Quality Assurance role at ELEXES Medical Consulting Pvt. Ltd. is an excellent opportunity for freshers who want to enter the medical device regulatory and quality domain. With exposure to global regulatory frameworks, strong mentorship, and real project work, this role can act as a solid foundation for a long-term RA/QA career.
If you are serious about building expertise in medical device regulations, this opportunity is worth applying for.
Disclaimer
Note: Pharma Duniya does not charge any money for job information.
Candidates are advised to verify details from the official company website.
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