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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.
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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
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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.
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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