Job Title

Regulatory Affairs Specialist

Job Description

Regulatory Affairs Specialist, Computed Tomography

The Regulatory Affairs Specialist for CT/AMI collaborates across functions to recommend and implement improvements to regulatory systems and processes, updates SOPs and templates, and applies regulatory knowledge to solve moderately complex challenges. The role supports audits, mentors junior team members, and manages change activities to ensure regulatory compliance for product labeling, manufacturing, supplier, design, and software updates.

Your role: 

• Collaborates across functions to recommend and implement improvements to regulatory systems and processes.
• Updates SOPs and templates, applying regulatory knowledge to address moderately complex challenges.
• Implements global regulatory strategies and roadmaps, ensuring alignment with organizational objectives through a strong understanding of the competitive market and product marketing.
• Supports audits, mentors junior team members, and manages change activities for regulatory compliance in product labeling, manufacturing, supplier, design, and software updates.
• Ensures regulatory compliance by combining market landscape insights with organizational goals.

You're the right fit if: 

• You've acquired 2+ years of related medical device industry regulatory experience with a bachelor’s degree or higher.  Experience working with radiation-emitting devices strongly preferred.

• Your skills include international registration experience, and CE marking experience. 510(k) authoring experience is a plus. NMPA submission experience is nice to have.

• You have a bachelor's or master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. RAPS certification preferred.

• You're an excellent communicator, with a strong ability to collaborate with cross-functional stakeholders. You are willing and able to travel up to 10% based on business needs.

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-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 here. 
• Discover our rich and exciting history here. 
• Learn more about our purpose here. 

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.