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
- Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a focus on Human Factors across development, registration, commercialization, and lifecycle management. Maintain and communicate CMC/...PlatformRegulatoryNight shift
$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 Lead and develop a team of regulatory leaders and subject...RegulatoryMinimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$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
$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 (34...PlatformRegulatoryWork at officeRemote workRelocation package$148.5k - $214.5k
...MSAT Industrialization Leader, Drug Product Synthetics - Location:... ...Job The DP Industrialization Lead ensures that drug product processes... ...receiving launch unit as RUL Regulatory & Compliance Contribute to and... ...sub‑team CMC DP sub‑team CMC platform M&S platform Tech Transfer...PlatformRegulatoryContract 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
$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$177k - $278.08k
...accelerate and differentiate our drug discovery capabilities. This... ...sciences, and digital platforms to assess opportunities for partnership... ...emerging capabilities, leading technical diligence, and partnering... ...role for a leader who combines scientific credibility, strategic...PlatformMinimum wageFull timeTemporary workWork at officeLocal area2 days per week3 days per week- 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
$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$110k - $125k
...clinical studies focusing on solid organ platforms. This role involves data management,... ...operations, and ensuring compliance with regulatory standards. The candidate should have at... ...research, preferably within the medical device or pharmaceutical industry. The position...PlatformRegulatoryRemote job$130k - $230k
Lead Clinical Data Management, ClinicalData Management, R&D, Orion... ...development decisions, regulatory submissions, and corporate objectives... ...technologies, automation platforms, and advanced analytics... ...professionals in the field of drug discovery and development. We...PlatformRegulatoryImmediate start- 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
- Scorpion Therapeutics is seeking a Regulatory Strategy Lead in Boston, MA. This role involves developing regulatory strategies focusing on Human Factors for devices and drug-device combinations. The ideal candidate will have over 10 years of regulatory CMC experience and...PlatformRegulatory
$220k - $260k
...writer with deep expertise in clinical and regulatory documents and demonstrated experience... ...document generation. The ideal candidate combines strong scientific and regulatory writing... ...language models, document intelligence platforms, structured authoring systems,...PlatformRegulatory$180k - $220k
...company with a mission to be the leading RNA editing company... ...human health. Our proprietary platform is based on groundbreaking research... ...NGS, etc.) in alignment with regulatory and clinical timelines.... ...uncover disease biology and drug response signals that inform...PlatformRegulatory3 days per week$201k - $251k
.../ GovRAMP Compliance Program Lead to build and lead our authorization... .... The ideal candidate combines expertise in FedRAMP, GovRAMP... ...management skills to translate regulatory requirements into practical,... ..., or similar regulated platforms. Excellent program management...PlatformRegulatoryTemporary workWorldwide- ...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
$129.3k - $177.8k
...our caring community The Lead Network Architect designs and... ...physical and virtual networking devices within our SDI environments.... ...challenges of technology, regulatory, security, and competitive conditions... ...Data Centers / Private Cloud platforms supporting multiple software...PlatformRegulatoryFull timeTemporary workFor contractorsWork at officeRemote workWork from homeHome office- ...quality leadership for assembly manufacturing of medical devices and combination products. You will oversee product disposition, batch records... ..., CAPAs, change controls, supplier quality, and regulatory compliance. You will collaborate with manufacturing, engineering...Regulatory
$167k - $300.7k
...Global Competitive Intelligence Lead-Oncology to lead Moderna’s... ...pipelines, clinical trial data, regulatory strategies, commercial... ...quickly learn regulatory and drug development environments Demonstrated... ...with AI‑driven CI platforms, digital dashboards, and foresight...PlatformRegulatoryWork from home$62.5k - $91k
...assigned. Position : Inpatient Lead Coder Department : Clinical... ...Clinic guidelines and other regulatory guidelines as appropriate. Consults... ...program. An equivalent combination of education and experience,... ...text messages or social media platforms. We do not ask individuals to...PlatformRegulatoryFull timeFixed term contractFlexible hours$90k - $119k
...experienced Engagement Manager to lead managed services engagements... ...and related interoperability platforms. This role is responsible for... ...reliable service delivery, regulatory compliance, and alignment... ...strategic ownership role that combines relationship leadership, commercial...PlatformRegulatoryContract workTemporary workWorldwide$237.2k - $372.79k
...Join us as a Global Medical Lead, Dermatology in our Cambridge... ...strategy, market access, and regulatory strategies, leads cross‑functional... ...Utilizes digital tools and platforms to share and update medical... ...telemedicine, mobile apps, wearable devices, and digital therapeutics....PlatformRegulatoryTemporary workWork at officeLocal areaWeekend work- ...Global Atopic Dermatitis Medical Lead Location: Cambridge, MA /... ...the highest ethical, regulatory, and scientific standards. This... ...strategy both for product and device development as well as possible... ...webinars, and interactive online platforms to reach a broader audience...PlatformRegulatoryWorldwide
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