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
- Cure Talent is seeking a Regulatory Manager to lead project delivery and regulatory strategy for drug-device combination products. This role will involve mentoring team members while remaining hands-on in project execution and regulatory documentation. The ideal candidate...Regulatory
- ...seeking a Senior Director and Regulatory Platform Lead in Boston, MA to provide strategic... ...for combination products and devices. The candidate will develop... ...reports, and deep knowledge of global regulatory processes. Takeda offers a hybrid working model and various...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$238k - $374k
Takeda is seeking an Executive Director for Global Regulatory Affairs in Boston, MA. This role will provide strategic leadership on regulatory affairs for medical devices and drug-device combination products, ensuring compliance and timely approvals. The ideal candidate...Regulatory- ...is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development... ...innovative regulatory strategies for device and drug-device combinations. This position... ...regulatory strategies, interfacing with global health authorities, and ensuring high...Regulatory
- Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a focus on Human Factors across development... ...and foundational subject matter expert for global Human Factors regulation for devices/...RegulatoryNight shift
$212k - $333.19k
...patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will provide... ...driving prospective and proactive implementation. Globally influences and serves as a key opinion leader and...RegulatoryFull timeTemporary workLocal areaWorldwideNight shift- 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
- ...to define and execute the strategy for drug-device combination product development. The role... ...Successful candidates will demonstrate a strong regulatory background and proven experience in leading complex technical projects. This hybrid position offers a competitive salary and...Regulatory
$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- Takeda is seeking a Senior Director and Regulatory Platform Lead in Boston to develop innovative regulatory strategies for combination products... ...collaborate with cross-functional teams and lead interactions with global health authorities, ensuring regulatory filings meet high...Regulatory
- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Regulatory
- ...Fircroft company is seeking a Senior Medical Device Engineer in Boston, Massachusetts. This role focuses on developing drug delivery devices and combination products, requiring... ...execution in design, testing, and regulatory compliance. The ideal candidate has over 8 years...Regulatory
- ...Engineering Principal Scientist to manage sustaining engineering activities for drug delivery devices. This role involves maintaining design documentation while ensuring compliance with regulatory standards. The successful candidate will work closely with cross-functional...Regulatory
- Biogen, Inc. is seeking a Head of Quality for Device and Combination Products to lead global quality strategy at our Cambridge, MA headquarters. The role... ...requires a visionary leader to ensure compliance with regulatory standards, oversee quality management, and support...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$122.25k - $176.58k
Job title: GRA Device Associate-Digital Health Location: Cambridge... ..., MA About the job The Global Regulatory Affairs (GRA) Device team... ...alone or in combination with a drug product, leading regulatory efforts in the... ...projects in a fast-paced, hybrid work environment (60% on-site...RegulatoryFull timeLocal areaWorldwide$188k - $258.5k
Purpose of the Role To lead and coordinate combination... ..., and usability of drug delivery systems, with... ...factors integration and regulatory readiness. Roles and Responsibilities... ...alignment of device strategy across... ...development. Familiarity with global regulatory frameworks...RegulatoryTemporary work- ...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
- 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
- ...Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs CMC Development in Cambridge, MA. In this hybrid position, you will be responsible for implementing the global regulatory CMC strategy, shaping... ...affairs, with experience in drug substance development and strong...Regulatory
$10k
## Head of Quality, Device and Combination... ...Products, you will lead the development and execution of the global quality strategy, focusing... ...representative for drug-device combination... ...and aligning regulatory regulations within... ...products.This is a hybrid-based role to be located...RegulatoryTemporary workLocal area$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- Takeda is looking for an experienced regulatory affairs professional to develop and lead global regulatory strategies for precision medicine and digital health... ...in regulatory affairs, particularly with medical devices and diagnostics. The ideal candidate will have a strong...RegulatoryRemote work
- ...in Boston is seeking a Regulatory Strategy Associate Director... ...for overseeing global and regional regulatory... ...of regulatory affairs, drug development, and experience... ...offers the flexibility of a hybrid or on-site working... ...potential bonuses, and market-leading benefits. #J-18808-...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... ...Information**Vertex is a global biotechnology company...RegulatorySummer workFlexible hours$177k - $278.08k
.../ 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... ...up to 120 hours of paid vacation. Hybrid work arrangement: This position is...RegulatoryMinimum wageTemporary workLocal areaRemote work$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid) Job Description Orion Pharma is a purpose-driven biopharmaceutical... ...documents across all phases of drug development and global regulatory submissions, ensuring quality and...RegulatoryWorldwide
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