Job Opportunity: Executive Consultant – Medical Devices

Job Summary

HL Associates is seeking a detail-oriented and motivated professional to join our team as an Executive Consultant – Medical Devices in Ahmedabad, Gujarat. This role is specifically designed for fresh graduates and early-career professionals in Biotechnology, Microbiology, and Biomedical sciences who are eager to build a career in medical device regulatory affairs. The successful candidate will gain comprehensive exposure to CDSCO compliance, ISO 13485 quality systems, and national regulatory frameworks, playing a vital role in supporting our clients through the complex medical device submission process.

Job Overview

• Position: Executive Consultant – Medical Devices
• Company: HL Associates
• Location: Ahmedabad, Gujarat (On-site)
• Employment Type: Full-time
• Experience: Freshers or professionals with up to 1 year of experience
• Compensation: ₹2.0 – ₹2.5 LPA (Approximate)

Key Responsibilities

As an Executive Consultant, you will work closely with our senior regulatory team to ensure that our clients’ products meet all necessary legal and quality standards. Your core responsibilities will include:

• Regulatory Documentation: Compiling and preparing CDSCO regulatory applications, including MD-5, MD-06, MD-9, MD-10, MD-15, and MD-42 licenses.
• Compliance Support: Assisting in the execution of BIS certification and CRS registration processes.
• Regulatory Strategy: Contributing to medical device classification and the preparation of regulatory strategies.
• Client Coordination: Liaising with clients to gather essential technical documentation, testing reports, and compliance data.
• Official Communication: Drafting regulatory declarations, technical justifications, undertakings, and formal correspondence.
• Query Management: Tracking the status of regulatory submissions and drafting responses to CDSCO queries.
• Quality Systems: Supporting the documentation and implementation of Medical Device Quality Management Systems (MDQMS).
• File Maintenance: Maintaining accurate regulatory files and documentation in strict adherence to Standard Operating Procedures (SOPs).
• Audit Support: Assisting in the preparation for regulatory audits, facility inspections, and client meetings.
• Market Intelligence: Monitoring and documenting updates related to Indian Medical Device Rules (MDR 2017) and evolving CDSCO guidelines.

Requirements

We are looking for candidates who possess a strong academic foundation and a keen interest in the regulatory landscape.

Educational Qualifications:

• Bachelor’s or Master’s degree (B.Sc/M.Sc) in Biotechnology, Microbiology, or Biomedical Sciences.

Experience:

• Fresh graduates are encouraged to apply.
• Candidates with up to 1 year of professional experience in regulatory affairs or the medical device industry will be preferred.

Core Skills:

• Foundational knowledge of Medical Device Rules (MDR 2017).
• Understanding of CDSCO regulatory processes and workflows.
• Familiarity with ISO 13485 and medical device quality management frameworks.
• Strong technical writing skills with a high level of attention to detail.
• Excellent communication skills, with the ability to coordinate effectively between clients and regulatory authorities.
• Analytical mindset and the ability to interpret complex regulations.

Benefits of Joining HL Associates

Choosing a career with us offers a robust professional foundation in a highly specialized field:

• Industry Entry: A direct pathway into the competitive medical device regulatory affairs sector.
• Skill Development: Hands-on experience with real-world CDSCO submissions, audits, and compliance strategies.
• Professional Exposure: Work directly with leading medical device manufacturers and gain insights into ISO 13485 and ISO 14971 risk management frameworks.
• Mentorship: Collaborative environment with opportunities to learn from senior regulatory consultants.

How to Apply

If you are passionate about regulatory compliance and are eager to grow your career in the medical device sector, we would love to hear from you.

Please submit your updated CV to the following email address:
📧 Email: [email protected]

HL Associates is an equal opportunity employer. We look forward to receiving your application.