Job Description

Function Description

This role supports the implementation of regulatory strategies and submissions for smaller-scale projects, coordinating cross-functional efforts to ensure compliance, streamline approvals, and maintain audit-ready documentation throughout the entire product lifecycle.

Your responsibilities:

• Support the implementation of regulatory strategies for smaller and less complex projects in collaboration with regulatory and other specialists; assist in the preparation and coordination of product submissions, compliance assessments, and change control processes, focusing on streamlining approvals and maintaining compliance.
• Review labeling, marketing materials, and development quality reports to ensure regulatory compliance; maintain documentation to support regulatory registrations, audits, and UDI/GTIN related activities.
• Work closely with internal teams and regional regulatory partners to align regulatory standards, support establishment registrations, and guide cross-functional stakeholders on evolving regulations and requirements.
• Operate under general supervision, within standardized procedures, using independent judgment and basic analytical skills to resolve less complex issues, accompanying senior specialists on maintenance and NPI (new product introduction) projects.
• Stay updated on changes in regulatory procedures and participate in continuous improvement initiatives to optimize internal regulatory operations and support more agile business outcomes.

Requirements

• Completed Higher Education in Biomedical Engineering, Health Sciences, Pharmacy, Administration, Law or related areas.
• Advanced English - you will be part of a global team.
• Proven experience in preparing and conducting international submissions (new registrations, renewals, and product change notifications) with regulatory authorities in different countries.
• Knowledge of global regulatory legislations and requirements (e.g., FDA, EMA, Health Canada, ANVISA).
• Familiarity with regulatory management tools (Windchill, SAP, RMSIS) is desirable.
• RAPS RAC certification will be considered a differential.

How we work together

We believe that we make a greater impact when we are together than apart. For our office team members, this means working in person at least three days a week, to collaborate and connect with others.

On-site positions require the employee to be present at the company's facilities at all times. For employees in a field position, their duties are performed more effectively outside the company's facilities, usually at client or supplier facilities.

This role is administrative – hybrid model;

About Philips

We are a health technology company. We built our entire company on the belief that all human beings matter and we won't stop until everyone, everywhere, has access to the quality healthcare we all deserve. Do the work of your life to help improve the lives of others.

Learn more about our businesses.

Discover our rich and exciting history.

Learn more about our purpose.

If you are interested in this role and have many, but not all, of the required experiences, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.