Global QMS Lead, Medical Devices & Compliance
Ninjakitchen
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. The ideal candidate has 7–10 years of experience with quality systems in medical devices, strong understanding of relevant standards, and excellent cross-functional influence. Benefits include medical, dental, vision insurance, 401(k) matching, and generous paid time off. #J-18808-Ljbffr Ninjakitchen
$85.6k - $149.4k
...Dormont Manufacturing Co is seeking a Senior Regulatory Affairs Specialist to steer regulatory compliance for our Software as a Medical Device (SaMD) portfolio. This pivotal role involves guiding teams through compliant product development and representing the company...Medical device- ...Management Systems to design and scale their quality programs. This role is critical in advancing compliance and inspection readiness, ensuring a commercial-ready QMS aligned with global standards. With a focus on leadership and operational excellence, the ideal candidate will...Suggested
$181k - $286.96k
...Director of Quality for Internal Audit and Compliance Engineering. This leadership role is responsible for overseeing the global Internal Audit program and ensuring... ...have at least 15 years of experience in the medical device industry, including experience with FDA regulations...Medical device3 days per week$238k - $374k
...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...Medical device- ...experienced regulatory affairs professional to develop and lead global regulatory strategies for precision medicine and digital health... ...of experience in regulatory affairs, particularly with medical devices and diagnostics. The ideal candidate will have a strong ability...Medical deviceRemote work
$238k - $374k
...JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20 years... ..., with significant expertise in regulatory submissions for medical devices and combination products. You will oversee a team to develop...Medical device$90.1k - $153.3k
...of choice. Job Summary The Global Category Manager for Indirect... ...Category Manager develops, leads, and executes corporate sourcing... ...management and contract compliance monitoring by partnering with... ...agreements and programs preferred Medical device or manufacturing experience...Medical deviceHourly payContract workTemporary workMonday to FridayFlexible hours- ...seeking a Senior Product Safety & Compliance Engineer to oversee regulatory compliance... ...role requires collaboration with global teams to ensure safety and... ...and over 5 years of experience in medical device regulations, capable of leading projects through complex compliance...Medical device
- A leading health-technology company in Cambridge, MA, is seeking a... ...quality processes and ensure compliance with FDA regulations. The successful... ...in quality operations within medical device manufacturing and will be... ...for risk assessments, QMS documentation, and cross-functional...Medical deviceFull time
$170k - $220k
...enabled technologies. This role involves developing regulatory approaches for Software as a Medical Device (SaMD) and serving as a primary advisor to cross-functional teams on compliance and strategic guidance. The ideal candidate will have a Bachelor’s degree, over 8 years...Medical device$125.8k - $239k
...A leading medical device company seeks a Senior Manager in Global Supply Chain Planning to oversee demand forecasting and inventory management. This role involves collaboration with divisional planners and team leadership to ensure operational efficiency. Candidates should...Medical deviceWorldwide- ...Sanofi is seeking a Global Project Head (GPH) for Ophthalmology to lead key development activities. This pivotal position involves managing strategy and... ...across multiple projects while ensuring regulatory compliance and collaboration with internal R&D leaders. The ideal...
- ...A global health technology firm in Cambridge, MA seeks a Global Product Manager for Mobile... ...to shape product strategies and lead the execution of go-to-market initiatives... ...management, especially in telehealth or medical devices. Responsibilities include overseeing product...Medical device
- ...Focus) Act as U.S. regulatory lead for clinical and medical device products, overseeing FDA... .... Ensure ongoing compliance with 21 CFR Part 820, ISO... ...MDSAP requirements. Support QMS implementation, internal/external... ...Program Leadership Lead global clinical studies from concept...Medical deviceRemote work
- ...New Hampshire is seeking an experienced Global Leader, Business Development for its MEDICAL Interventional Solutions. This role involves leading growth strategies, developing market... ...in market analysis within the medical device industry, and proven leadership skills....Medical device
$178.5k - $257.83k
...Director, US Advertising and Promotion, Global Regulatory Affairs Location: Morristown... ...functions (e.g., Communications, Compliance, Legal) to foster open communication and... ...required Experience within pharmaceutical or medical device Regulatory Affairs Successful track...Medical device$270k - $330k
...Overview The Senior Director, Global Regulatory Affairs, Oncology... ...reimbursement considerations. Lead regulatory consultation... ...line with Ipsen’s ethics and compliance policies. Knowledge & Experience... ...Preferred Knowledge Knowledge of medical device/drug device combination...Medical deviceTemporary workWorldwideFlexible hours$140k - $190k
Role, Inc. is seeking a Field Quality Manager to oversee quality initiatives across Boston, MA. The ideal candidate will manage failure analysis programs and ensure product quality through effective methodologies. This role requires a Bachelor's degree in Engineering and...Medical device$120k - $225k
...Wellington Management Company is seeking a Global Benefits Lead to oversee the operational management of the firm's global benefit programs, particularly US health and welfare and retirement plans. The ideal candidate will have 10+ years of HR/benefits experience and...Work from home1 day per week$177k - $278.08k
...Objective / Purpose: Defines, develops and leads global strategies to maximize global... ...maintenance of programs, while ensuring compliance with applicable regulatory requirements... ...employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan...Minimum wageTemporary workLocal areaRemote work- ...ZoomInfo is seeking a Manager of SOX Compliance in Boston to lead the execution of their SOX program. This role involves managing a global team, partnering with external auditors, and shaping ZoomInfo's approach to risk as it scales. The ideal candidate will have extensive...
- ...commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance with FDA regulations, and preparing regulatory submissions. Ideal candidates will have a bachelor’s degree, extensive experience...Medical deviceRemote job
- ...Sig Sauer, headquartered in Newington, New Hampshire, is seeking a Sr. Manager, Global Tax to oversee tax planning and compliance efforts. The role involves managing transfer pricing documentation and collaborating with internal teams and external advisors. The ideal candidate...Work at office
$212k - $333.19k
...impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... .... U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match,...Minimum wageTemporary workLocal areaWorldwide- ...vendor oversight. The candidate will manage regulatory databases, maintain compliance with global standards, and prepare submission-ready documents. The position offers an opportunity to lead cross-functional teams and contribute to critical regulatory processes in a...
- ...Mass Digital Health is looking for a Global Labeling Strategist to shape the future of medicine. This role involves leading the development and maintenance of global labeling... ...for products, ensuring regulatory compliance while working with cross-functional teams....
- ...A leading biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves managing post-approval change activities, ensuring compliance with global regulations, and leading efforts to standardize processes. Candidates should possess...
- ...Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy... ...responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory requirements. The ideal candidate will have...
$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... .... U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match,...Minimum wageTemporary workLocal areaImmediate startRemote workWorldwide$320k - $380k
...ambition to become the leading dermatology company in... ...Key Responsibilities Global Clinical Operations Strategy... ...budget, and within compliance and regulatory... ..., Regulatory Affairs, Medical Affairs, Program Management... ...Experience with medical devices, injectables, or...Medical deviceContract workTemporary workWork experience placementShift work
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