Medical Devices jobs in Mumbai, Maharashtra

Job Title: Regulatory Affairs Specialist

Location: Mumbai

Department: Regulatory Affairs

Industry: Aesthetic / Medical Devices

Role Overview

The Regulatory Affairs Specialist will be responsible for ensuring that all products comply with applicable regulatory requirements in India and relevant international markets. The role involves managing product registrations, approvals, documentation, and coordination with regulatory authorities.

Key Responsibilities

Handle product registration and licensing with CDSCO and other regulatory bodies

Prepare, review, and submit regulatory dossiers for medical devices / aesthetic products

Ensure compliance with Medical Device Rules (MDR), 2017 and applicable guidelines

Coordinate with internal teams (R&D, QA, Sales) for regulatory documentation and updates

Maintain and update regulatory files, technical documentation, and product certifications

Monitor changes in regulatory requirements and ensure timely implementation

Support audits, inspections, and compliance activities

Liaise with external consultants and regulatory authorities for approvals

Manage import licenses, labeling compliance, and post-market surveillance activities

Key Requirements

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related field

5 years of experience in regulatory affairs (medical devices / pharma / aesthetics)

Strong knowledge of CDSCO regulations and Indian regulatory framework

Experience in dossier preparation and submission

Good understanding of ISO standards (e.g., ISO 13485) is an added advantage

Strong documentation, analytical, and communication skills

Preferred Skills

Experience in handling import registrations and licensing

Familiarity with international regulations (USFDA, CE Marking)

Attention to detail and ability to manage multiple submissions simultaneously

Why Join Us

Opportunity to work in a high-growth aesthetic and medical device company

Exposure to end-to-end regulatory processes

Dynamic and collaborative work environment

Career growth in a specialized domain

Pay: ₹239,009.50 - ₹1,186,409.94 per year

Work Location: In person