Regulatory Affairs Expert
il y a 5 jours
Senior Regulatory Affairs Specialist
Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Philips. As a key member of our Regulatory Affairs department, you will be responsible for ensuring that our medical devices comply with all relevant safety and environmental policies and regulations.
Key Responsibilities- Regulatory Strategy and Planning
Develop and implement comprehensive regulatory strategies for complex software devices and significant post-market changes.
Regulatory Submission and ManagementPrepare and submit regulatory submissions, including US 510(k), EU MDR Technical File, and global/international submissions.
Regulatory Compliance and Risk ManagementEnsure product compliance with applicable regulations and internal procedures, and manage product change control processes.
Collaboration and CommunicationCollaborate with internal and external stakeholders, including commercial teams, to ensure regulatory requirements are met.
Requirements- Education and Experience
Bachelor's or Master's degree in engineering, law, life sciences, pharmacy, medicine, or a relevant discipline, with 5+ years of experience in the medical device industry.
Skills and KnowledgeStrong background in Design Controls, medical device regulations (21CFR), FDA law, MDD, and other global laws and standards.
Language and CommunicationFluent in written and spoken English, with excellent communication and collaboration skills.
About PhilipsWe are a health technology company committed to improving people's lives through innovative solutions. Our purpose is to make a meaningful difference in the lives of 3 billion people every year by 2030.
At Philips, we believe that every human matters, and we strive to create a workplace that is inclusive, diverse, and empowering. If you're passionate about making a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.
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