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Philips is seeking a Senior Regulatory Specialist to develop and execute regulatory strategies for medical device product development and compliance. The ideal candidate will have extensive regulatory experience, particularly in submissions and interactions with regulatory bodies, and will be expected to work onsite at least three days a week.
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Job Summary
The Senior Regulatory Specialist will develop and execute regulatory strategies for new product development and design changes across the US, EU, and Rest of World.
This role requires mastering FDA 21 CFR 820, EU MDR, and ISO 13485 to lead submissions such as 510(k) and Health Canada license applications.
Candidates must possess 7-10 years of industry experience and demonstrate the ability to guide cross-functional teams on global regulatory landscape changes.
Matching Summary
Match Score: 75
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Philips is seeking a Senior Regulatory Specialist to develop and execute regulatory strategies for medical device product development and compliance. The ideal candidate will have extensive regulatory experience, particularly in submissions and interactions with regulatory bodies, and will be expected to work onsite at least three days a week.
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Skills & Requirements
Must-have
7-10 years regulatory affairs experience
FDA 21 CFR 820 Quality System Regulations mastery
EU MDR Regulation 2017/745 application expertise
ISO 13485 standard knowledge
510(k) submission authoring capability
Nice-to-have
Master's degree in engineering or regulatory affairs
Experience leading pre-sub meetings with regulators
Strong negotiation skills with competent authorities
Ability to mentor and coach other team members
Process improvement initiative leadership
Key Requirements
Minimum 7-10 years in Medical Device Regulatory Affairs
Bachelor's or Master's degree in Engineering or Regulatory Affairs