Regulatory Affairs Specialist

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.