Job Description

About Company and Product:

We are a FemTech focused Medtech company in the Preventive Oncology and TeleHealth space, designing, developing and commercializing globally adoptable and clinically effective, Non-invasive Cancer Pre-screening Solutions for Women. The company's flagship product iBreastExam (iBE) is a US FDA cleared and CE marked, non-invasive, radiation-free and painless solution for identifying non-palpable breast lumps to enable early detection of breast cancer for women across all ages and demographics.

Job Title:

Regulatory Affairs Associate / Executive

Job Summary:

We are seeking a highly motivated Regulatory Affairs professional to support regulatory submissions, product registrations, compliance activities, and liaison with health authorities. The role involves ensuring that our products meet all applicable regulatory requirements in India and international markets.

Key Responsibilities:

Prepare, compile, and submit regulatory dossiers for product registrations, amendments, and renewals in India and overseas markets.

Prepare, review, and maintain CE Technical Documentation in compliance with EU MDR 2017/745.

Coordinate with Notified Bodies for CE Marking submissions, renewals, and responses to queries.

Maintain up-to-date knowledge of applicable regulatory requirements (CDSCO, US FDA, EU MDR, MDA Malaysia, etc.) and ensure organizational compliance.

Support preparation and review of technical documentation (STED, CSDT, CE Technical Files, etc.).

Coordinate with cross-functional teams (Quality, R&D, Manufacturing, Commercial) to gather required documents and information for regulatory submissions.

Liaise with regulatory authorities, consultants, and distributors for queries, clarifications, and approvals.

Support audits and inspections by regulatory authorities and Notified Bodies.

Ensure product labelling, packaging, and promotional material comply with regulatory requirements.

Participate in change control assessments from a regulatory perspective.

Maintain regulatory databases and track submission/approval timelines globally.

Qualifications & Skills:

Bachelor's / Master's degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, or related field.

1-5 years of experience in Regulatory Affairs (medical devices or pharmaceuticals), with minimum 1 year hands-on CE Marking experience (EU MDR 2017/745).

Experience in preparing CE Technical Documentation and working with Notified Bodies.

Knowledge of global regulatory frameworks (CDSCO, US FDA, ASEAN, WHO.

Strong documentation and organizational skills.

Excellent communication and coordination abilities.

Ability to manage multiple projects simultaneously.

Preferred Attributes:

Prior experience with Class II / III medical device registrations in EU and India.

Familiarity with international submissions across SE Asia, Middle East, LATAM, etc.

Ability to interpret regulatory requirements and provide practical guidance to teams.

Excellent communication and coordination abilities.

Detail-oriented, with the ability to manage multiple projects simultaneously.

Job Types: Full-time, Permanent

Pay: ₹20,000.00 - ₹50,000.00 per month

Benefits:

Health insurance Provident Fund
Application Question(s):

Current CTC? Expected CTC? Notice Period (and if negotiable)? Current residential Location? Experience inRegulatoryAffairs (with specific details onregulatorysubmissions, product approvals, documentation, etc.)? Experience in CE Marking? Reason for exploring a job change?
Work Location: In person