Regulatory Affairs and Quality Assurance Intern

Maven Profcon Services

0 - 2 years

0 Lacs

ahmedabad

Posted:Just now| Platform:

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Skills Required

service contracts usfda data analysis iso 13485 manager quality assurance qms gap analysis hr regulatory affairs internship

Work Mode

Work from Office

Job Type

Internship

Job Description

Regulatory Affairs and Quality Assurance Intern

Roles & Responsibilities:

Conduct research on regulations, new topics, and global guidelines.
Assist in preparing regulatory documents, country registration files, and NB application forms.
Support creation and maintenance of regulatory databases.
Prepare QMS documents (SOPs, forms, templates) and assist in audit-related documentation.
Create training materials, PPTs, questionnaires, and client learning content.
Assist in vigilance data, PMS/PMCF documentation, and standard gap analysis.
Perform data analysis and support miscellaneous tasks such as formatting, data sorting, and searching IFUs/CE certificates.
Prepare AMC service contracts and monthly planning sheets.
Support team members with documentation and tasks assigned by the manager.

What You Will Gain:

Hands-on exposure to global regulatory requirements (EU-MDR, IVDR, US FDA, ISO 13485).
Experience in preparing real-time regulatory and QMS documentation.
Opportunity to contribute to client projects and regulatory submissions.
Mentorship from experienced regulatory professionals.
Practical knowledge that strengthens your career in Regulatory Affairs & Quality Assurance.

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