Sr. RA-QA Executive

Maven Profcon Services

1 - 4 years

10 - 15 Lacs

ahmedabad

Posted:2 weeks ago| Platform:

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Skills Required

iso project management product design life sciences risk management regulatory affairs biomedical auditing technical documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Develop, review, and maintain regulatory documentation in accordance with EU MDR 2017/745, including technical documentation, risk management files, and clinical evaluation reports.
Conduct gap assessments against EU MDR requirements to identify areas for improvement and support implementation strategies.
Coordinate with cross-functional teams to gather data and ensure alignment of regulatory submissions with product design and development processes.
Stay updated on relevant regulatory testing requirements and ensure compliance with applicable standards.
Support the preparation of Notified Body submissions, responses to queries, and audit readiness.
Assist in the compilation and submission of US FDA 510(k) dossiers, including predicate device analysis and regulatory strategy.
Interpret global regulatory requirements and translate them into clear guidance and actionable plans for internal and client teams.

Qualifications & Skills:

Bachelor s or Master s degree in life sciences, biomedical engineering, pharmacy, or a related field.
Minimum 1-4 years of hands-on experience in regulatory affairs within the medical device industry.
Demonstrated expertise in EU MDR 2017/745, with experience preparing clinical, risk, and performance documentation.
Strong understanding of ISO 14971 and MEDDEV guidance.
Familiarity with FDA 21 CFR Part 820 and 510(k) submission process is a plus.
Excellent communication, documentation, and project management skills.
Ability to work independently, prioritise tasks, and manage deadlines across multiple projects.

If this role aligns with your aspirations and experience, we d be excited to connect with you! Please submit your application using the form below.

Please fill out the application form to ensure your submission is properly recorded.

Please note: Only shortlisted candidates will be contacted after the application is submitted. We kindly request you not to call or WhatsApp unless contacted by our HR team.

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