Regulatory Affairs Specialist

Philjobs

Onsite
Regulatory systems and processes improvement
Product labeling and manufacturing compliance
Cross-functional collaboration
The Regulatory Affairs Specialist collaborates across functions to recommend and implement improvements to regulatory systems and processes

Job Summary

  • The Regulatory Affairs Specialist collaborates across functions to recommend and implement improvements to regulatory systems and processes.
  • This role supports audits, mentors junior team members, and manages change activities to ensure regulatory compliance for product labeling, manufacturing, supplier, design, and software updates.
  • Philips is a health technology company committed to providing quality healthcare access worldwide and values diversity and inclusion.

Matching Summary

The Regulatory Affairs Specialist collaborates across functions to recommend and implement improvements to regulatory systems and processes.

Skills & Requirements

Must-have

  • Regulatory systems and processes improvement
  • Product labeling and manufacturing compliance
  • Cross-functional collaboration
  • International registration experience
  • CE marking experience

Nice-to-have

  • Mentoring junior team members
  • Supporting audits
  • Travel up to 10%
  • Strong communication skills
  • Understanding of competitive market

Key Requirements

  • 2+ years medical device regulatory experience
  • Bachelor’s or master’s degree in relevant field
  • Experience with radiation-emitting devices preferred
  • RAPS certification preferred
  • 510(k) authoring experience is a plus
  • NMPA submission experience is nice to have

Work Rights

Not specified

Tailored Resume

Cover Letter