Regulatory Affairs Specialist

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:

Regulatory Affairs Executive

Key Responsibilities:

gap analysis

Prepare and maintain regulatory submissions including:

• Device Master Files

• Risk Management Files

• Design History Files

• Clinical Evaluation Reports

• Usability Reports

Instructions for Use (IFUs)

regulatory submissions

Purchase, Accounts, Legal, Marketing

audit-related queries

new product developments

Stay updated with changes in regulatory requirements and industry trends through self-learning and structured training.

Educational Qualifications:

Pharmaceutical Sciences

Regulatory Affairs

Experience:

1 to 4 years

Hands-on experience with global and domestic regulatory submissions.

Exposure to documentation systems and regulatory portals (CDSCO/SUGAM/NSWS) is essential.

software regulations

Key Skills and Competencies:

Strong knowledge of:

Regulatory frameworks

Risk management

documentation, analytical

Microsoft Office Suite

Strong interpersonal skills to collaborate with internal departments and external bodies

Soft Skills:

Go-getter attitude

English proficiency

organizational

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/