Regulatory Affairs Specialist

Job Description

Job Title:

Regulatory Affairs
No of Vacancy:1

Job Location:

Andheri West
Years of

Experience:

1-4 years
Working Days:
Monday to Saturday

Job Summary:

We are seeking a motivated and detail-oriented  Regulatory Affairs Executive  to join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with domestic and international regulations across global markets including India, the US, and the EU. This role requires strong coordination skills and a proactive approach to support product registrations, audits, and technical submissions.

Key Responsibilities:

Conduct  gap analysis  of existing regulatory and technical documentation.
Prepare and maintain regulatory submissions including:
Device Master Files
Risk Management Files
Design History Files
Clinical Evaluation Reports
Usability Reports
Draft and update product labeling content such as  Instructions for Use (IFUs) ,  implant cards , and  declarations  to meet global compliance requirements.
Support  regulatory submissions  for India (via CDSCO/SUGAM/NSWS), US (FDA), EU (CE marking under MDR), and other applicable markets.
Coordinate with cross-functional teams including  Purchase, Accounts, Legal, Marketing , and  R&D  to gather documentation and resolve queries.
Assist in preparing and submitting responses for  audit-related queries  and regulatory inspections.
Contribute to regulatory strategy for  new product developments  and modifications.
Stay updated with changes in regulatory requirements and industry trends through self-learning and structured training.

Educational

Qualifications:

Bachelor’s or Master’s degree in  Pharmaceutical Sciences ,  Engineering ,  Biotechnology ,  Microbiology , or a related life science field.
Specialization in  Regulatory Affairs  or  Quality Assurance  preferred.

Experience:

1 to 4 years  of industry experience in a Regulatory Affairs role, preferably in medical devices, pharmaceuticals, or life sciences.
Hands-on experience with global and domestic regulatory submissions.
Exposure to documentation systems and regulatory portals (CDSCO/SUGAM/NSWS) is essential.
Experience or knowledge of  software regulations  is an added advantage.

Key Skills and

Competencies:

Strong knowledge of:
Regulatory frameworks  including ISO 13485, EU MDR, and 21 CFR Part 820
Risk management ,  design controls , and  post-market surveillance
Excellent  documentation, analytical , and  technical writing skills
Proficient in  Microsoft Office Suite  and digital documentation platforms
Strong interpersonal skills to collaborate with internal departments and external bodies

Soft Skills:

Go-getter attitude  with the willingness to lead and take initiative
High  English proficiency  – both verbal and written
Strong  organizational  and  time management  skills
Ability to work independently and as part of a  cross-functional team.
Fast learner with a proactive mindset for continuous development.

Monday to Saturday working
Company Website: