HL Associates has announced a Medical Device Regulatory Affairs job opening for the position of Executive Consultant – Medical Devices in Ahmedabad, Gujarat. This opportunity is ideal for fresh graduates and early-career professionals in Biotechnology, Microbiology, and Biomedical sciences who want to build a career in medical device regulatory affairs, CDSCO compliance, and quality management systems.
The role provides exposure to Indian Medical Device Rules (MDR 2017), CDSCO regulatory submissions, ISO 13485 quality systems, and BIS certification processes, making it a valuable entry point for candidates interested in medical device regulatory consulting.
Candidates will work closely with senior regulatory consultants to prepare regulatory documentation, support audits, and manage compliance submissions for medical device manufacturers and importers.
Job Details
- Position: Executive Consultant – Medical Devices
- Company: HL Associates
- Location: Ahmedabad, Gujarat, India
- Employment Type: Full-time
- Experience: Freshers / Up to 1 year
- Salary: Approximately ₹2.0 – ₹2.5 LPA
- Work Mode: On-site
Key Responsibilities
Selected candidates will assist regulatory consultants with medical device regulatory compliance and documentation activities, including:
- Preparing and compiling CDSCO regulatory applications such as MD-5, MD-06, MD-9, MD-10, MD-15, and MD-42 licenses
- Supporting BIS certification and CRS registration processes
- Assisting in medical device classification and regulatory strategy preparation
- Coordinating with clients to collect technical documentation, testing reports, and compliance data
- Drafting regulatory declarations, justifications, undertakings, and official communications
- Tracking regulatory submissions and responding to CDSCO queries
- Assisting in Medical Device Quality Management System (MDQMS) documentation and implementation
- Maintaining regulatory files and documentation as per SOP requirements
- Supporting regulatory audits, inspections, and client meetings
- Monitoring updates related to Indian medical device regulations and CDSCO guidelines
Eligibility Criteria
Candidates interested in this Medical Device Regulatory Affairs job should meet the following requirements:
Educational Qualification
- B.Sc or M.Sc in:
- Biotechnology
- Microbiology
- Biomedical Science
Experience
- Freshers can apply
- Candidates with up to 1 year experience in regulatory affairs or medical devices will be preferred
Skills Required
Candidates applying for this medical device regulatory consultant role should possess:
- Basic knowledge of Medical Device Rules (MDR 2017)
- Understanding of CDSCO regulatory processes
- Familiarity with ISO 13485 and medical device quality systems
- Strong documentation and regulatory writing skills
- Ability to coordinate with clients and regulatory authorities
- Good communication and analytical skills
Benefits of This Role
Working as an Executive Consultant – Medical Devices at HL Associates provides several career advantages:
- Entry into the medical device regulatory affairs industry
- Hands-on experience with CDSCO submissions and regulatory documentation
- Exposure to ISO 13485 and ISO 14971 risk management frameworks
- Opportunity to work with medical device manufacturers and regulatory consultants
- Skill development in compliance, audits, and regulatory strategy
How to Apply
Interested candidates can apply by sending their updated CV to the contact details below.
📧 Email: bdm@hl-associates.in