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Concept Medical
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Regulatory Affairs Associate

Regulatory Affairs Associate

Concept Medical

2 - 3 years

4 - 5 Lacs

Surat

Posted:1 day ago| Platform:

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Skills Required

Regulatory Affairs Associate ISO Compliance RAC Project management Regulatory affairs Monitoring Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

ROLES &
RESPONSIBILITY

Develop regulatory strategies for new/existing products.

Ensure compliance with local/international regulations (CDSCO, ISO, FDA).

Prepare and submit regulatory submissions.

Monitor regulatory developments and adjust strategies.

Liaise with regulatory bodies and internal teams for compliance.

Conduct audits and maintain up-to-date knowledge of regulatory requirements.

Required Qualifications:

Bachelor s degree in a scientific discipline.

2 to 3 years experience in regulatory affairs within the medical device industry.

In-depth knowledge of CDSCO, ISO, FDA standards.

Experience with regulatory submissions and medical device development.

Excellent communication, organizational, and project management skills.

Preferred Qualifications:

Advanced degree (Master s/Ph.D.).

Professional certification in regulatory affairs (RAC).

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Regulatory Affairs Associate