Regulatory Platform Lead, Drug-Device Combinations & HF
JobRx, Inc.
Takeda is seeking a Senior Director and Regulatory Platform Lead in Boston to develop innovative regulatory strategies for combination products, focusing on Human Factors. This role demands over 10 years of industry expertise, including leadership responsibilities and regulatory compliance. The successful candidate will collaborate with cross-functional teams and lead interactions with global health authorities, ensuring regulatory filings meet high standards. Excellent communication and problem-solving skills are essential, along with the ability to manage complex projects effectively. #J-18808-Ljbffr JobRx, Inc.
- Takeda is seeking a Senior Director and Regulatory Platform Lead in Boston, MA to provide strategic leadership in regulatory affairs for combination products and devices. The candidate will develop and implement regulatory strategies with a focus on Human Factors, ensuring...PlatformRegulatory
$212k - $333.19k
...order to bring life‑changing therapies to patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will provide leadership for the development and implementation of innovative pure...PlatformRegulatoryFull timeTemporary workLocal areaWorldwideNight shift- Takeda is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development of innovative regulatory strategies for device and drug-device combinations. This position requires over 10 years of experience in the pharmaceutical industry, with...PlatformRegulatory
$238k - $374k
...Therapeutics, Inc. is looking for an Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and drug-device combination products. The successful candidate will have 20+ years of...Regulatory$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product, you will provide strategic leadership and... ..., EU, UK, Japan, China). How you will contribute Leads and develops a team of regulatory leaders and subject...RegulatoryTemporary workWork at officeLocal areaRemote workWorldwide$88.6k - $246.6k
...Solution Implementation Lead is the end‑to‑end... ...new connected medical device and digital health solutions... ...workflows, regulatory considerations, and validation... ...aptitude related to systems, platforms, integrations, and... ...degree or equivalent combination of education, training...PlatformRegulatoryFull timePart time$147k - $212k
...Job Title: GRA Device Lead (Associate Director) Location... ...is on to speed up drug discovery and development... .... The Global Regulatory Affairs (GRA) Device team... ...supporting the medical device, combination product, digital... ...AI, data, and digital platforms to push the boundaries...PlatformRegulatoryTemporary workLocal areaWorldwideFlexible hours- A global health innovation company is seeking an Executive Director for Global Regulatory Affairs to lead strategic initiatives for medical devices and drug-device combination products. The role requires over 20 years of industry experience with significant expertise in...RegulatoryWorldwide
$188k - $258.5k
Purpose of the Role To lead and coordinate combination product‑related... ...development, and usability of drug delivery systems,... ...integration and regulatory readiness. Roles and... ...alignment of device strategy across multiple... ...with auto‑injector platforms (e.g., YpsoMate) is...PlatformRegulatoryTemporary work$20k
...each vendor and software platforms. This includes main... ...radiologists, CT Division lead radiologists to ensure... ...-Assist in oversite of regulatory requirements pertaining... ...Commission (JC), Federal Drug Administration(FDA)-... ...6%) 35lbs+ (w/assisted device) Carrying Frequently...PlatformRegulatoryWork at officeRelocation package$20k
...each vendor and software platforms. This includes main... ...radiologists, CT Division lead radiologists to ensure... ...-Assist in oversite of regulatory requirements pertaining... ...Commission (JC), Federal Drug Administration(FDA)-... ...6%) 35lbs+ (w/assisted device) ~ Carrying Frequently...PlatformRegulatoryHourly payWork at officeRemote workRelocation packageShift work- ...leader to define and execute the strategy for drug-device combination product development. The role involves managing... ...Successful candidates will demonstrate a strong regulatory background and proven experience in leading complex technical projects. This hybrid position...Regulatory
$238k - $374k
JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20... ...significant expertise in regulatory submissions for medical devices and combination products. You will oversee a team to develop robust...Regulatory$126.6k - $189.8k
...Scientist focuses on combination product development, with... ...a particular focus on drug delivery systems. The... ...and Development, Device Quality Control, Device... ...& Labeling Functions, Regulatory Affairs, and Manufacturing... ...and externally.* Leads Design Reviews to completion...RegulatorySummer workFlexible hours$131k - $174k
...Description Summary Combined role with responsibility... ...' databases and platforms and responsibility for... ...architecture standards. Lead, coach, and develop database... ...Ensure compliance with regulatory, security, and internal... ..., and prescription drug coverage; access to a Health...PlatformRegulatoryPermanent employmentContract workFor contractorsRemote workVisa sponsorshipWork visaRelocation packageWeekend work$19.72 - $29.3 per hour
...POSITION SUMMARY: The Lead Emergency Technician is under the direction... ...and maintaining medical devices such as stretchers,... ...and Compliance - Awareness of regulatory standards (e.g., HIPPA, OSHA)... ...text messages or social media platforms. We do not ask individuals to...PlatformRegulatoryFull timeContract workFixed term contractImmediate startFlexible hours- ...novel micro-array patch platform. With only five... ...delivery. The platform combines high temperature stability... ...dramatically alter the way that drugs are delivered.... ...Specialist II, Device Engineering will support... ...safety, efficacy, and regulatory requirements. Administer...PlatformRegulatoryWork at office
$130k - $170k
...Incident Response Lead At WHOOP, we're on a mission to unlock... ...impact assessments and regulatory notification processes Drive... ...Hands-on expertise with SIEM platforms, EDR tools, and cloud security... ...view total compensation as the combination of base salary, equity, and benefits...PlatformRegulatoryFull timeWork at officeRelocation- ...preclinical validation of our innovative neuromodulation platform. This role involves designing studies to showcase the efficacy and safety of our device. You'll collaborate with experts, contributing to regulatory submissions and clinical trials. Your expertise in...PlatformRegulatory
$100k
...Maximus is seeking a Certification Lead to manage end-to-end... ...process improvement and supporting regulatory-driven program objectives.... ...Program (EAP). ?? Recognition Platform - Acknowledge and appreciate... ...required. ~ Equivalent combination of education and experience considered...PlatformRegulatoryRemote work- ...an experienced professional to lead CMC analytical development as... ...analytical strategy for siRNA drug substance and drug product, encompassing... ...of Aerska's delivery platform, including process-related and... ...line with ICH guidelines and regulatory expectations from MHRA and FDA...PlatformRegulatory
$70.51k - $105.76k
...focused on events, you will lead the planning and execution of... ...through execution. This role combines project management excellence... ...Knowledge of medical/legal/regulatory (MLR) processes and compliance... ...Familiarity with virtual event platforms (e.g., Zoom, Webex) and...PlatformRegulatory- Scientist/Senior Scientist, Biology Lead - Kidney Experience About the... ...and in vivo kidney research platforms that enable target discovery,... .... The ideal candidate combines extensive bench expertise in... ...chemistry, delivery, translational, regulatory, and external teams Help...PlatformRegulatory
- Ninjakitchen is seeking a Quality System Compliance Manager in Needham, MA to lead the QMS design and implementation for medical devices. This role focuses on ensuring regulatory compliance while embedding quality into the product development process across functions....Regulatory
- ...An experienced team member to lead Enterprise Risk Management and Liquidity Risk Management platforms projects as Solution... ...Basel II/III/IV, IFRS, DORA) and regulatory requirements for risk platforms... ...gathering, and documentation. • Combine exceptional interpersonal...PlatformRegulatory
$97k - $146k
...Development Engineer to join the Alexion Device Development organization. This role... ...requires overseeing technical deliverables for combination products and managing interactions with... ...medical device industry. Knowledge of regulatory compliance and strong collaboration skills...Regulatory- ...growth factor-targeted drugs can play a... ...application of a proprietary platform, which has developed... ...Product Development to lead formulation and drug... ...syringes, and autoinjector device combinations. Provide... ...engineering, clinical, and regulatory functions....PlatformRegulatory
$10k
## Head of Quality, Device and Combination ProductsApplyremote type: Hybridlocations... ...Products, you will lead the development and execution... ...quality representative for drug-device combination engagements... ...inspection readiness and aligning regulatory regulations within Biogen's...RegulatoryTemporary workLocal area$178.5k - $257.83k
...Title Sr. AI Driven Innovations Lead Location Morristown, NJ About... .... The race is on to speed up drug discovery and development to find... ...processing, analysis, and regulatory submission, ensuring alignment... ...influence technology strategy, platform selection, and build‑vs‑buy decisions...PlatformRegulatoryTemporary workFlexible hours- Biogen, Inc. is seeking a Head of Quality for Device and Combination Products to lead global quality strategy at our Cambridge, MA headquarters. The... ...requires a visionary leader to ensure compliance with regulatory standards, oversee quality management, and support both...Regulatory
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