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Regulatory and Compliance Engineer

Regulatory and Compliance Engineer

Philips

8 - 13 years

25 - 30 Lacs

pune

Posted:1 day ago| Platform:

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Skills Required

medical devices document review project management packaging healthcare continuous improvement stakeholder management biomedical risk mitigation auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

As a Regulatory & Compliance Engineer within the STET Grooming & Beauty (GB) team, you will play a key role in ensuring our products meet global regulatory, safety, and compliance standards throughout their lifecycle. You will support product registrations, safety certifications, documentation, and regulatory assessments while partnering closely with R&D, Quality, LCM, and Manufacturing teams.

Your role:

Manage and support regulatory activities for product changes and lifecycle maintenance.
Prepare, submit, and maintain regulatory documentation, approvals, and compliance records.
Review product labeling, packaging, and marketing materials to ensure regulatory compliance.
Track and interpret relevant regulatory changes and support their deployment across teams.
Coordinate product testing and safety evaluations, including engagement with external test houses.
Ensure adherence to internal policies, global standards, and quality system requirements.
Support internal and external audits with accurate, audit ready documentation.
Collaborate closely with cross functional teams to proactively manage compliance risks.

Youre the right fit if you have :

Bachelors / Masters Degree in Biomedical Engineering / any Engineering background.

Minimum required Experience:

Minimum 8 years of experience in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry

Preferred Skills: highest priority

Technical Product Documentation

Regulatory Submission Documentation

Conformity Assessment

Regulatory Requirements (particularly on major markets and jurisdictions, e. g. US CFR, EU MDR)

Standards (e. g. 60601 series, 14971, 62304)

Regulatory Compliance activities

Document Review / Auditing

Product Registrations

Product Labeling

Continuous Improvement

People Management

Preferred Skills: secondary priority

Strategy Implementation

Stakeholder Management

Regulatory Intelligence

Risk Mitigation Strategies

Project Management

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Philips

Healthcare Technology

Amsterdam

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Regulatory and Compliance Engineer