Global Regulatory Lead - Medical Devices (510(k)/EU MDR)
Philips Research (HealthTech and Lighting)
Philips in Cambridge, MA seeks a Senior Regulatory Affairs Specialist to lead regulatory strategies for 510(k) and EU MDR across advanced imaging hardware. You will partner with R&D, Quality, and Manufacturing to embed regulatory requirements into design and ensure global compliance. You will coordinate Notified Bodies, submissions, and post-market activities, while mentoring junior staff and communicating complex topics to senior leadership. This is an office-based role with travel up to 10%. #J-18808-Ljbffr Philips
$215k - $230k
...Description About Spryte Medical At Spryte Medical,... ...Director of Regulatory Affairs to lead the development and execution of global regulatory strategies... ...s innovative medical device portfolio. This individual... ...De Novo, PMA, 510(k), IDE, EU MDR, and international market...RegulatoryMedical deviceFor contractorsLocal area- Philips is seeking a Sr Program Manager to drive EU MDR compliance initiatives for the Sleep & Respiratory Care team. You will lead cross-functional programs from planning through execution, balancing scope, budget, and regulatory requirements while engaging stakeholders and...Regulatory
- Philips in Cambridge, MA is seeking a Senior Regulatory Affairs Specialist to drive regulatory initiatives for CT/AMI hardware. You will lead 510(k) and EU MDR activities, interact with Notified Bodies, and influence design inputs for compliant hardware systems across...RegulatoryMedical device
$242k - $270k
...Director, Senior Global Regulatory Lead (Sr. GRL) Global Regulatory Strategy (GRS) Location: King... ...major regions, including the US, EU, and/or Japan. Demonstrated experience... ...stakeholders. Strong clinical development or medical device expertise is highly desirable....RegulatoryMedical device3 days per week- Pulpdent seeks a Head of Regulatory Affairs to lead global regulatory strategy across the product lifecycle... ...ideal candidate has 10+ years in medical device regulatory affairs, strong... ...and deep knowledge of FDA QSR and EU MDR frameworks. #J-18808-Ljbffr PulpdentRegulatoryMedical device
- ...Watertown, MA, seeks a Head of Regulatory Affairs to guide global regulatory strategy... ...manufacturing, and marketing. Lead a high-performing team,... ...ensure compliance with EU MDR and ISO 13485. This on-... ...candidate has 10+ years in medical devices regulatory affairs, a...RegulatoryMedical deviceWorldwide
$225k - $260k
...everything we do. As a global leader with the most... ...Advanced Staining Reagents leads scientific aspects of... ..., R&D, Clinical, Regulatory, Commercial, Sales and... ...pathology, software as a medical device and oncology or cancer... ...insurance and 401(k) to eligible employees...RegulatoryMedical deviceFull timeRemote workWork from homeFlexible hours- ...Head of Regulatory Affairs About the Company... ...and software as a medical device Industry Medical... ...and execute global regulatory strategies... .... The role will lead regulatory submissions... ..., including 510(k), De Novo, PMA, IDE... ...regulations, ISO 13485, EU MDR, IVDR, and global...RegulatoryMedical device
- ...Compliance Engineer, Medical Devices Location: Greater... ...certification, regulatory compliance, and... ...role partners with global product... ...Responsibilities Lead product certification... ...devices, including FDA 510(k) submissions, EU Medical Device Regulation (MDR) requirements,...RegulatoryMedical deviceContract work
- ...is an industry-leading dental research... ...are distributed globally. Pulpdent is... ...The Head of Regulatory Affairs will lead... ...regulatory submissions (510(k)s, technical... ...Class I & II, devices), 510(k)s,... ...registrations (EU MDR, UKCA, etc.).... ...experience in medical devices; exposure...RegulatoryMedical device
$154.4k - $242.55k
...teams for the delivery of global regulatory strategies to support... ..., diagnostic tests, devices and digital health... ...Responsible for developing and leading the global regulatory... ...working with medical devices and/or diagnostics... ...market support, including EU MDR and IVDR.Understands...RegulatoryMedical deviceMinimum wageLocal areaRemote work- ...Associate Director, Global Regulatory Affairs Ipsen... ..., France and the U.K, we tackle areas of high unmet medical need through research... ...addition, the role leads or contributes to operational... .... Knowledge of EU and Asia Pacific (... ...of medical device / drug device combination...RegulatoryMedical deviceLocal areaWorldwide
$137k - $236k
...for Strategic Regulatory leadership and... ...software enabled medical devices with focus on major... ...the US and EU. Proactively provide... ...of global regulations that... ...development partners and lead/enable strong... ...submissions (510(k)s, De Novo, 513(g) etc.), EU MDR process,...RegulatoryMedical deviceWork visa$137k - $217k
Job TitleSenior Regulatory Affairs SpecialistJob... ...and compliant with global regulatory requirementsYour... ...expert for 510(k) and CE Mark/EU MDR compliance, including... ...and complex device portfolios.Lead and influence global... ...within FDA regulated Medical Device environments...RegulatoryMedical deviceFull timeWork at officeImmediate startRelocationWork visa3 days per week- ...Summary:Reporting to the Medical Head the Senior Global Medial Affairs Lead Cardiovascular is a highly... ...system pathways, regulatory landscapes, market access... ...markets (e.g., US, China, EU), and successfully developing... ...retirement program [401(k) plan]; paid vacation and...RegulatoryHourly payFull timeTemporary workWork at officeWorldwide3 days per week
$133.5k - $192.83k
...safety, and regulatory compliance of... ...expertise including EU IVDR, FDA 21... .... Join a global network that... ...including PMA, 510(k), IDE, IND,... ...diagnostic partners; lead laboratory... ...Drug‑device combination products... ...of MDSAP (Medical Device Single... ...handling, MDR/vigilance reporting...RegulatoryMedical deviceWorldwide$192.8k - $260.8k
.... The Associate Medical Safety Director... ...support medical device safety assessment... ...including evaluation of MDR-related cases... ...health threats, regulatory reporting,... ...Safety Product Leads to investigate potential... ...applicable FDA, EU, and ICH... ...accounts and a 401(k)with a generous...RegulatoryMedical deviceFull timeTemporary workRemote workFlexible hours$227k - $362k
...Philips is hiring a Global Marketing Leader to build and lead the Claims, Value & Pricing team for Hospital... ...excellence or related work in a global medical device or healthcare technology business... ...working with clinical, regulatory, legal, quality and commercial teams...RegulatoryMedical devicePrice workFull timeWork experience placementWork at office3 days per week$117k - $157k
...Engineer II in the Device Development... ..., Quality, Regulatory Affairs, Clinical... ...plans.Lead technical issues... ...experience developing medical devices and/or... ...1 CFR Part 4, 510(k), PMA, MDD, MDR, and other... ...applicable US and EU regulatory... ...Biogen?We are a global team with a...RegulatoryMedical deviceFull timeContract workTemporary workLocal area$175k - $220k
...Associate Director of Regulatory Affairs to lead regulatory strategy... ...Develop and execute US and global IVD regulatory... ...Pre-Submissions, IDEs, 510(k)s, De Novo requests,... ...affairs experience in medical devices, including substantial... ...knowledge of US and EU IVD requirements, design...RegulatoryMedical device$121k - $193k
...TitleSr Program Manager, EU MDRJob DescriptionSr... ...EU MDRDrive critical EU MDR compliance initiatives and... ...Respiratory Care (SRC) team by leading cross-functional programs that ensure regulatory milestones are delivered... ..., and in a complex global working environment.How...RegulatoryFull timeWork at officeImmediate startWork visaRelocation package3 days per week$150k - $180k
...and/or post‑market regulatory activities for digital... ...analyzing software medical device products and... ...promoting compliance with global digital health... ...modifications. Prepares FDA 510(k), Health Canada license and EU Notified Body... ...to either EU MDR or EU IVDR Effective...RegulatoryMedical device- ...operations – Opportunities in the US and EU Location: U.K, Europe and U.S Salary: Competitive... ...consultancies, or be working within a regulatory agency. The US position(s) will be... ...discipline. Experience of working globally and an understanding of cultural...RegulatoryFull timeWork at officeRemote work
- Takeda is seeking a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies to drive strategic labeling across CCDS, US and EU labels while coordinating with internal stakeholders to ensure regulatory compliance and successful product evolution. This role...RegulatoryRemote job
$177k - $278.08k
...lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team... ...requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus. Experience in managing major...RegulatoryMinimum wageFull timeLocal areaRemote workWorldwide- ...Job Title: Sr. Regulatory Affairs Principal... ...compliance with global regulations and leading the process to obtain... ...(FDA Class III) devices. Represent... ...requirements for high risk medical devices. Lead... ...-submission, US 510(k)s submissions,... ...Regulations (MDR 2017/745, MDCG 2...RegulatoryMedical deviceWork at officeLocal areaRemote work
$232.5k - $320k
## Global Brand Lead, NavtemadlinPostuler: Cambridge (US): Temps complet: Offre publiée... ...ability to lead through influence across Medical, Market Access, Regulatory, Insights, Finance, Supply, Legal,... ...benefits package, including 401(k) with company contributions, group...RegulatoryTemporary workLocal areaFlexible hours$92.2k - $141.4k
...SharkNinja is a global product design... ...Compliance Engineer - Medical DevicesNPD... ...- Medical Devices & Consumer ProductsThe... ...all aspects of regulatory compliance and... ...role: you will lead multiple... ...products subject to EU MDR 2017/745... ...filings — FDA 510(k) submissions and...RegulatoryMedical deviceTemporary workLocal areaFlexible hoursShift work- Organogenesis Inc. is seeking an experienced Regulatory Affairs professional in Canton, MA to lead regulatory strategies and submissions for medical devices and biologics. You will collaborate... ..., with expertise in PMA/IND/BLA/510(k) submissions and lifecycle management....RegulatoryMedical device
$177k - $278.08k
...lasting impact on patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team... ...requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus.Experience in managing major regulatory...RegulatoryMinimum wageLocal areaRemote workWorldwide
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