Regulatory Affairs Specialist

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 Bachelors degree
• 2+ 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.

Indicate if 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.