Analyst – Regulatory Management (Medical Devices) | Merck Life Science, India

Biopractify; Bengaluru; On-site; INR 600,000 - 700,000; Full time

Job summary

Merck Life Science India is hiring an Analyst – Regulatory Management (Medical Devices). This entry-level role is ideal for freshers and early-career professionals seeking a career in global medical device regulatory affairs.

You will support regulatory submissions, maintain compliance documents, and collaborate with quality, regulatory, and cross-functional teams across international markets. Proficiency with Veeva Vault or Mango is a plus.

Qualifications

• Master's degree in Life Sciences, Biomedical Engineering, Biotechnology or related field.
• 0–2 years of experience in Regulatory Affairs or Quality Assurance.
• Familiar with global medical device regulations such as FDA, EU MDR/IVDR, TGA, and Health Canada.
• Knowledge of Technical Documentation (TD) and GSPR.
• Proficient with document management systems like Veeva Vault or Mango.
• Strong communication, documentation, organizational and time-management skills.

Responsibilities

• Support regulatory submissions for Medical Devices and IVDs across global markets.
• Prepare, review, track and maintain regulatory compliance documentation.
• Assist with FDA, EU MDR/IVDR, Health Canada and TGA regulatory submissions.
• Support TD and GSPR documentation.
• Manage regulatory documents using Mango and Veeva Vault.
• Collaborate with quality, regulatory and cross-functional teams to ensure compliance.

Skills

Regulatory Affairs

Quality Assurance

Documentation

Veeva Vault

Mango

Communication

Education

Master's degree in Life Sciences

Tools

Mango

Veeva Vault

Job description

Analyst – Regulatory Management (Medical Devices) | Merck Life Science, India

Institution: Merck Life Science (via FYND Talent Solutions)

Position Available: Analyst – Regulatory Management (Medical Devices)

Research/Functional Area: Medical Device Regulatory Affairs | Regulatory Compliance | Life Sciences | In Vitro Diagnostics (IVD)

Merck Life Science is inviting applications for the position of Analyst – Regulatory Management (Medical Devices). This opportunity is ideal for freshers and early-career professionals looking to build a career in global medical device regulatory affairs. The role involves supporting regulatory submissions, maintaining compliance documentation, and collaborating with cross-functional teams to ensure regulatory excellence across international markets.

What You’ll Work On

Support regulatory submissions for Medical Devices and IVDs across global markets.

Prepare, review, track, and maintain regulatory compliance documentation.

Assist with FDA, EU MDR/IVDR, Health Canada, and TGA regulatory submissions.

Support Technical Documentation (TD) and General Safety & Performance Requirements (GSPR) documentation.

Manage regulatory documents using Mango and Veeva Vault systems.

Collaborate with quality, regulatory, and cross-functional teams to ensure compliance.

Qualifications

You hold a Master’s degree in Life Sciences, Biomedical Engineering, Biotechnology, or a related discipline.

You have 0–2 years of experience in Regulatory Affairs, Quality Assurance, or a related field.

You understand global medical device regulations such as FDA, EU MDR/IVDR, TGA, and Health Canada.

You are familiar with Technical Documentation, GSPR, and document management systems like Veeva Vault or Mango.

You possess excellent communication, documentation, organizational, and time-management skills.

What You’ll Gain

Work with one of the world’s leading science and technology companies.

Exposure to global Medical Device and IVD regulatory processes.

Opportunity to collaborate with experienced regulatory and quality professionals.

Hands‑on experience with industry-standard regulatory documentation systems.

Excellent career growth in Medical Device Regulatory Affairs.