Regulatory Affairs Specialist 2

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Job Title
Regulatory Affairs Specialist 2

Job Description

The Regulatory Affairs Specialist II plays a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) products are safe, effective, and compliant with global regulatory rules and standards. This role will provide cross-team support on key compliance and regulatory activities such as SOPs (Standard Operation Procedures) tracking audits and audit readiness.

Your responsibilities:

* Manage regulatory master data across PLM, RIM, and ERP platforms.

* Partner with internal teams and external stakeholders to streamline processes and solve challenges.

* Support establishment registration, product listings, and UDI/GTIN activities, ensuring smooth regulatory filings and licenses.

* Prepare and coordinate regulatory submissions for product licensing, driving accuracy and efficiency.

* Review product labeling and marketing materials to ensure compliance with global standards.

* Stay ahead of regulatory changes and contribute to continuous process improvements.

Requirements:

* Two or more years of experience in the medical device or other highly regulated industry where Quality Management Systems play a role in conformity with regulations.

* A bachelor's degree in a scientific or engineering discipline

* Strong written, oral, and interpersonal skills to effectively compose agency submissions and collaborate cross-functionally.

* A demonstrated ability to support multiple projects, function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines

* Experience in the use of MS Office and Adobe Acrobat. Knowledge of PLM software, such as Windchill is a plus.

* High level of English, as the person will be interacting with people from different countries.

Qualifications:

* Knowledge in RMSYS

* Ability to work across teams and manage multiple priorities.

* Attention to detail and commitment to compliance.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

This is an administrative/office-based role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
* Learn more about our business.
* Discover our rich and exciting history.
* Learn more about our purpose.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here