Regulatory Affairs Manager

Philips UK

United Kingdom
**
Implement global regulatory strategies
Safety risk assessments
Regulatory filings and licenses
** Philips UK is seeking a Regulatory Affairs Manager to implement global regulatory strategies for medical devices, ensuring compliance with safety standards and regulatory requirements. The ideal candidate will have a relevant educational background, preferably with experience in regulatory affairs or quality compliance, and will thrive in a collaborative, onsite work environment. **

Job Summary

  • Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives.
  • Resolves a wide range of moderate complexity requests in creative ways, leads comprehensive safety risk assessments to identify potential safety incidents and regulatory non-compliance, managing these incidents in Trackwise and ensuring corrective actions are effectively implemented.
  • Implements safety and compliance requirements for product development projects and OEM/ODM products, communicating and integrating regulatory standards into the I&D organization through memos, training sessions, and deployment strategies.

Matching Summary

Match Score: 75

** Philips UK is seeking a Regulatory Affairs Manager to implement global regulatory strategies for medical devices, ensuring compliance with safety standards and regulatory requirements. The ideal candidate will have a relevant educational background, preferably with experience in regulatory affairs or quality compliance, and will thrive in a collaborative, onsite work environment. **

Skills & Requirements

Must-have

  • implement global regulatory strategies
  • safety risk assessments
  • regulatory filings and licenses
  • product lifecycle regulatory planning
  • regulatory submissions development
  • marketing and labeling compliance

Nice-to-have

  • continuous improvement within regulatory framework
  • proactive regulatory risk management
  • collaboration with cross-functional teams
  • enhancements in systems and processes

Key Requirements

  • Bachelor's / Master's Degree
  • Minimum 2 years of experience with Bachelor's
  • RAPS RAC certification preferred

Work Rights

Not specified

Tailored Resume

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