Regulatory Affairs Specialist

1 - 4 years

0 Lacs

Posted:7 hours ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

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:

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/

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Illusion Dental Laboratory

Medical Equipment Manufacturing

Mumbai Maharashtra

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