Hybrid Senior Regulatory Affairs Specialist-Medical Devices
3 weeks ago
A leading medical device company is seeking a Senior Regulatory Specialist to manage regulatory submissions to the FDA and EU. This hybrid role requires a Bachelor’s Degree and at least four years of experience in regulatory affairs. Responsibilities include developing strategies for regulatory approval, coordinating submissions for various product classifications, and ensuring compliance with regulatory standards. Strong communication skills and experience in the medical device industry are preferred.
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Senior Regulatory Affairs Specialist
3 weeks ago
Cambridge, United States Boston Scientific Gruppe Full timeAbout this role The Senior Regulatory Specialist is responsible for planning, authoring, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting worldwide product approvals and registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change...
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Global Regulatory Affairs Device Lead
4 weeks ago
Cambridge, United States Scorpion Therapeutics Full timeOverviewJob title: Global Regulatory Affairs Device Lead (Associate Director)Location: Morristown, NJ or Cambridge, MA or Framingham, MAAbout the JobAre you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams...
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Senior Regulatory CMC Device Lead
4 weeks ago
Cambridge, United States Biogen Full timeSenior Regulatory CMC Device LeadAs the Senior Regulatory CMC Device Lead, you will play a pivotal role in providing Regulatory CMC expertise to support the development and implementation of global regulatory strategies for combination products and medical devices. Your focus will be on single-entity combination product development, such as prefilled...
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Senior Regulatory CMC Device Lead
1 week ago
Cambridge, MA, United States Biogen Full timeSenior Regulatory CMC Device Lead As the Senior Regulatory CMC Device Lead, you will play a pivotal role in providing Regulatory CMC expertise to support the development and implementation of global regulatory strategies for combination products and medical devices. Your focus will be on single-entity combination product development, such as prefilled...
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Quality and Regulatory Affairs Director
4 days ago
Cambridge, United States Aspire Life Sciences Search Full timeOur client is a fast-growing MedTech start-up based in Boston, developing next-generation ophthalmology devices. With clinical milestones progressing, FDA interactions underway, and an ambitious commercial roadmap, they are entering a critical phase of scaling and are now looking to hire a Director of Quality & Regulatory Affairs. The role As Director of...
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Quality and Regulatory Affairs Director
2 weeks ago
Cambridge, United States Aspire Life Sciences Search Full timeOur client is a fast-growing MedTech start-up based in Boston, developing next-generation ophthalmology devices. With clinical milestones progressing, FDA interactions underway, and an ambitious commercial roadmap, they are entering a critical phase of scaling and are now looking to hire a Director of Quality & Regulatory Affairs. The role As Director of...
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Quality and Regulatory Affairs Director
1 week ago
Cambridge, United States Aspire Life Sciences Search Full timeOur client is a fast-growing MedTech start-up based in Boston, developing next-generation ophthalmology devices. With clinical milestones progressing, FDA interactions underway, and an ambitious commercial roadmap, they are entering a critical phase of scaling and are now looking to hire a Director of Quality & Regulatory Affairs.The roleAs Director of...
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Quality and Regulatory Affairs Director
7 days ago
Cambridge, United States Aspire Life Sciences Search Full timeOur client is a fast-growing MedTech start-up based in Boston, developing next-generation ophthalmology devices. With clinical milestones progressing, FDA interactions underway, and an ambitious commercial roadmap, they are entering a critical phase of scaling and are now looking to hire a Director of Quality & Regulatory Affairs. The role As Director of...
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Quality and Regulatory Affairs Director
1 day ago
Cambridge, MA, United States Aspire Life Sciences Search Full timeOur client is a fast-growing MedTech start-up based in Boston, developing next-generation ophthalmology devices. With clinical milestones progressing, FDA interactions underway, and an ambitious commercial roadmap, they are entering a critical phase of scaling and are now looking to hire a Director of Quality & Regulatory Affairs. Increase your chances of...
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Quality and Regulatory Affairs Director
2 weeks ago
Cambridge, MA, United States Aspire Life Sciences Search Full timeOur client is a fast-growing MedTech start-up based in Boston, developing next-generation ophthalmology devices. With clinical milestones progressing, FDA interactions underway, and an ambitious commercial roadmap, they are entering a critical phase of scaling and are now looking to hire a Director of Quality & Regulatory Affairs. The role As Director of...