Regulatory Affairs Specialist

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Job Description

Job Title

Regulatory Affairs Specialist

Job Description

The Regulatory Affairs Specialist provides regulatory guidance for business unit product lines. The Regulatory Affairs Specialist works directly with cross functional teams to support global product market clearances .

Your Role

• Act as the Regulatory Affairs representative for CT/AMI products, supporting regulatory activities such as labeling, marketing, technical documentation, global registrations, and regulatory design change assessments within the product Development Life Cycle.
• Provide regulatory guidance to cross-functional teams throughout all design control phases for new products and major/minor changes.
• Coordinate and prepare document packages to support global submissions and regulatory activities.
• Support regulatory audits and compliance activities.
• Serve as the local regulatory liaison between markets and the BIU site.
• Maintain Product Shipment Authorization for CT/AMI product lines, ensuring compliance with localization and licensing requirements
  
  

You're The Right Fit If You Have

• A relevant academic degree
• 2-3 years of experience in a regulated and technical environment
• Knowledge of global regulations for successful preparation and submission of regulatory documentation
• Strong English communication skills (written and oral)
• Team player with the ability to collaborate effectively with cross-functional teams
  
  

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.

Onsite roles require full-time presence in the company’s facilities.

Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This role is an office 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 commitment to diversity and inclusion here.

Apply Now

Embrace the unexpected

Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.

Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did.

Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team.

We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally.

Working at Philips is more than a job. It's an experience filled with unexpected moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.