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Regulatory Affairs Executive

2 weeks ago

Mumbai, Maharashtra, India Illusion Dental Laboratory Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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:

l Device Master Files

l Risk Management Files

l Design History Files

l Clinical Evaluation Reports

l 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