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Global Appliances
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Regulatory/Compliance Executive

Regulatory/Compliance Executive

Global Appliances

2 - 7 years

|

2 - 6 Lacs

noida new delhi gurugram

Posted:2 weeks ago| Platform:

Apply

Skills Required

cdsco regulatory compliance regulatory affairs clinical research

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Handle
clinical and regulatory processes from application to approval
for medical devices.
Must have strong knowledge of the
CDSCO application, review, and approval process
for medical devices in India.
Prepare and maintain
regulatory documents, technical files, and dossiers
for submissions.
Support
CDSCO, CE, and ISO 13485 requirements
.
Coordinate with internal teams for
documentation, product information, and testing reports
.
Assist in
Clinical Evaluation Reports (CER/CEE)
, risk management files, and
Post-Market Surveillance (PMS)
reports.
Ensure
timely submission, follow-up, responses, and renewal
of licenses and approvals.
Maintain updated knowledge of
EU MDR, Indian MDR, and CDSCO guidelines
.
Ensure
audit readiness
and provide support during
regulatory inspections
.

Preferred candidate profile

Bachelors/Master’s in Life Sciences, Pharmacy, Biomedical Engineering, or related field.
1–5 years’ experience in
regulatory approvals/clinical documentation
(medical device or pharma).
Strong knowledge of
CDSCO
approval processes.

quality standards

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