Global Regulatory Lead, Devices & Drug-Device Combos (Hybrid)
$238k - $374kInitial Therapeutics, Inc.
Initial 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 industry experience in regulatory affairs, with a proven track record in managing submissions and aligning cross-functional teams. The position offers a hybrid work model, competitive salary ranging from $238,000 to $374,000, and comprehensive benefits including medical insurance, 401(k) matching, and paid vacation. #J-18808-Ljbffr
$212k - $333.19k
...worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors,... ...and proactive implementation. Globally influences and serves as a key opinion... ...is currently classified as hybrid following Takeda's Hybrid and Remote...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwideNight shift- ...Scorpion Therapeutics in Cambridge, Massachusetts, is seeking a Regulatory Affairs leader to oversee global regulatory strategy for medical devices and drug-device combination products. The role requires extensive experience in regulatory submissions and compliance with...Regulatory
$238k - $374k
...worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product, you will... ...China). How you will contribute Leads and develops a team of regulatory leaders... ...is currently classified as "hybrid" following Takeda's Hybrid and Remote...RegulatoryTemporary workWork at officeLocal areaRemote workWorldwide$238k - $374k
...Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership... ...in regulatory submissions for medical devices and combination products. You will oversee... ...timely approvals. The position is hybrid and offers a compensation range of $238...Regulatory$142.73k - $237.88k
...GlaxoSmithKline in Waltham, MA is seeking a Device Lead for Global MSAT Drug Delivery and Aseptic Technology. This role emphasizes leading device... ...The ideal candidate should have extensive experience in regulatory compliance, project management, and cross-functional leadership...Regulatory- ...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... ...position is classified as hybrid and based in Boston, MA. #J...RegulatoryWorldwide
- ...Therapeutics is seeking an enterprise regulatory leader based in Cambridge,... ...defining and executing global regulatory strategies for plasma... ...sourcing, collection, and devices, ensuring compliance with health... ...ability to influence and lead diverse teams. The position requires...Regulatory
- ...How you will contribute: Lead and develop a team of regulatory leaders and subject matter experts; oversee global regulatory strategy and major submissions for a portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution...Regulatory
$114.6k - $234.6k
...Job Description At a time when global technological developments and... ...sciences sector. As Global Medical Device & Life Sciences Policy Director, you will lead regulatory policy efforts impacting our... ...’s business from the Food & Drug Administration and similar global...RegulatoryTemporary workFlexible hours$147k - $212k
...Job Title: GRA Device Lead (Associate Director) Location: Cambridge... ...The race is on to speed up drug discovery and development to... ...accelerate progress. The Global Regulatory Affairs (GRA) Device team is... ...projects in a fast-paced, hybrid work environment (60% on-site...RegulatoryTemporary workLocal areaWorldwideFlexible hours$124.61 - $138.45 per hour
...Consultant in Cambridge, MA, to lead activities for a Class III implantable medical device. The role requires experience in... ...execution, ensuring compliance with regulatory standards, and managing cross-... ...teams. The position offers a hybrid work model with competitive compensation...RegulatoryRemote jobHourly pay$88.6k - $246.6k
...The Solution Implementation Lead is the end-to-end execution... ...operationalization of new connected medical device and digital health solutions.... ..., operational workflows, regulatory considerations, and validation... ...of FDA guidelines and global regulatory expectations and their...RegulatoryFull timePart timeImmediate startWorldwide$154.4k - $242.55k
...Associate Director, Global Labeling Lead where you will be responsible... ...in various stages of drug development, which... ...processes conform to regulatory requirements.... ...Operations, Labeling Devices Lead and Labeling Compliance... ..." following Takeda's Hybrid and Remote Work...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$142.73k - $237.88k
...The Device Lead of Global MSAT Drug Delivery and Aseptic Technology will be the Technical owner of the Device platform and be globally accountable... ...the Device platform life – including post-approval regulatory change management, continued process verification, and continued...RegulatoryLocal area- ...A leading biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves managing post-approval... ..., ensuring compliance with global regulations, and leading efforts... ...of regulatory CMC relevant to drug development. Strong leadership...Regulatory
$137k - $215.27k
...professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a... ...managing submissions. The position offers a hybrid work model, with a salary range of $137,000...Regulatory- ...Consultant in Boston, Massachusetts, to lead quality management system implementations for medical device clients. In this full-time role... ...AI technology to ensure regulatory excellence. The ideal candidate... .... The role allows for a hybrid work schedule. #J-18808-Ljbffr...RegulatoryFull time
- ...Inc. is seeking an Associate Director, Global Labeling Lead in Cambridge, MA. This role involves... ...for products, ensuring compliance with regulatory standards. The successful candidate will... ...skills. The position fosters a hybrid work environment, offering competitive...Regulatory
$126.6k - $189.8k
...Engineering Senior Scientist in Boston to focus on drug delivery systems and combination product... ...design and implementation of medical devices. Candidates should have a Ph.D. with 2+... ...development, a thorough understanding of regulatory standards, and solid project management...Regulatory$90 - $130 per hour
...Job Title Project Manager (Medical Devices III) Position Type Contract Location Contract... ...validation, manufacturing readiness, and regulatory submission activities. The Project Manager... ...and program timelines. Responsibilities Lead integrated project plans focused on finalizing...RegulatoryContract work$90k - $130k
...Job Title : Device Quality Engineer - Device Risk Management... ...Excellence within our Global Device and Packaging Unit (GDPU), you will lead critical global... ...for patient safety and regulatory compliance. You are accountable... ...Medical Devices and Drug-Device Combination products...RegulatoryWorldwide- A leading medical device company in Boston is seeking a Quality Manager who will oversee validation and verification processes for new products... ...management. Strong analytical skills and knowledge of regulatory requirements are essential. This position offers a significant...Regulatory
$155k - $190k
...Nova Biomedical: One Global Brand. One Vision.... ...countries to speed drug development and... ...that meet clinical, regulatory, and business needs... ...design constraints Lead system-level trade... ...regulated medical device environments... ...reimbursement Hybrid and flexible work arrangements...RegulatoryHourly payWork at officeFlexible hours- ...seeking a Sr. Manager, R&D located in Boston, MA, to lead the development of innovative transplant devices that enhance organ preservation methods. The ideal... ...for overseeing multiple projects, ensuring regulatory compliance, and managing a team of engineers. A Bachelor...RegulatoryRemote work
$232.5k - $335.83k
Job title: Global Atopic Dermatitis Medical Lead Location: Cambridge, MA / Morristown, NJ... ...upholding the highest ethical, regulatory, and scientific standards.... ...both for product and device development as well as possible... ...it’s using AI to shorten drug-discovery times or...RegulatoryFull timeWorldwide$153.6k - $241.34k
...A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience... ..., MA, the position is hybrid and provides a competitive... ...a solid understanding of drug development processes. #J-...Regulatory$174.5k - $274.23k
.../ Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program... .... Solid working knowledge of drug development process and regulatory... ...position is currently classified as “hybrid” in accordance with Takeda’s...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote work- ...Group seeks a Principal Medical Device Engineer located in Cambridge, Massachusetts... .... In this role, you will lead the design and development of innovative drug delivery technologies and medical... ...while ensuring compliance with regulatory standards. With a minimum of 15 years...Regulatory
$109.25k - $149.5k
...regulated environment. The role requires expertise in quality systems, regulatory compliance, and risk management, including dFMEA and pFMEA.... ...extensive experience in quality engineering within the medical device or life sciences field. The position offers a salary range of $...Regulatory$126.6k - $189.8k
...a particular focus on drug delivery systems. The Product... ...and Development, Device Quality Control, Device... ...& Labeling Functions, Regulatory Affairs, and Manufacturing... ...and externally.Leads Design Reviews to completion... ...InformationVertex is a global biotechnology company that...RegulatorySummer workFlexible hours
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