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 :

https : / / www.laxmidentallimited.com /

https : / / www.illusiondentallab.com /

https : / / www.illusionaligners.com /