Global Regulatory CMC Director - Medical Devices & Combos
Talencio
A global leader in medical technology is seeking a Director of Global Regulatory Chemistry, Manufacturing, and Controls (CMC) for Medical Devices. This role, based in Connecticut, focuses on leading regulatory strategies to ensure compliance and product quality, impacting patient outcomes. Candidates should have over 12 years of experience in regulatory affairs, with a particular emphasis on medical devices. This position offers a hybrid work model with relocation support. #J-18808-Ljbffr
- ...Overview Introduction: Join a global leader driving... ...disease treatment by leading regulatory strategies that enable life... ...patients worldwide. As the Director of Global Regulatory Chemistry... ...Manufacturing, and Controls (CMC) for Medical Devices and Combination Products, you...Medical deviceFull timeWorldwideRelocation package
- ...the pharmaceutical, biotech, and medical device industries with our proven, scientific... ...to complex trial data and regulatory submission challenges. With a global footprint across four continents,... ...biostats, regulatory operations, and CMC Demonstrated ability to lead...Medical deviceFull timeRemote work
- ...highest safety, reliability, and regulatory standards. You will bridge... ..., manufacturing, and global regulatory compliance to maintain... ...reports directly to the Director of Regulatory and Quality Assurance... ...CFR Part 820 and ISO 13485 medical device standards. Product Risk &...Medical deviceFull time
$220k - $350k
...currently offer over 600 clinically relevant medical devices to healthcare providers, including... ...preferred.Experience working within global publicly traded medical device organizations... ...in industry associations, regulatory working groups, or standards organizations...Medical deviceWorldwide$23 - $26 per hour
...Delivery Assurance Field Representative Who We Are: Quest Global delivers world-class end-to-end engineering solutions by... ...aerospace & defense, automotive, energy, hi-tech, healthcare, medical devices, rail and semiconductor industries. We are looking for humble...Medical deviceHourly payFull timeTemporary workRemote work$250k
...technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose... ...to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature...Medical deviceMinimum wageOngoing contractLocal areaRemote workWorldwide- ...innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent...Medical deviceRemote jobWorldwide
- ...® (Sustained Acoustic Medicine) device family, we deliver wearable, home-use medical technologies that improve the quality... ...life for millions of patients globally. We collaborate extensively with... ..., and battery efficiency. Regulatory Compliance: Prepare documentation...Medical deviceFull time
$46k - $72k
...commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a... ..., including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical... ...staff, as well as customers and regulatory personnel. Responsibilities: Quality, Regulatory...Medical deviceHourly payFor contractorsImmediate startWorldwideFlexible hoursShift work- ...a bridge between technical software validation, testing, and regulatory compliance, ensuring systems operate reliably and remain in a... ...CSV) or software validation within pharmaceutical, biotech, or medical device industries. ~ Strong understanding of regulatory...Medical device
- ...Pharmacology, and Human Physiology. As a global healthcare leader, our proprietary platforms... .... Our innovations, including the sam® device, enable safe, in-home treatment, offering... ...patients to verify contact information and medical benefits. Instruct patients on the use of...Medical deviceFull timeWork at office
- ...currently offer over 600 clinically relevant medical devices to healthcare providers, including... ...leading and driving all aspects of the Global Supplier Quality Management Program.... ...role ensures supplier compliance with regulatory requirements, corporate quality standards...Medical device
$19.24 per hour
...required. · High School Diploma or GED required. Pay Details: $19.24 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K...Medical deviceHourly payTemporary workLocal areaImmediate startNight shiftWeekend work- ...currently offer over 600 clinically relevant medical devices to healthcare providers, including... ...Engineering, Operations, Procurement, Regulatory Affairs, R&D, Manufacturing, and business... ...drives continuous improvement across global supplier networks. About CooperSurgical...Medical device
$101.48k - $135.3k
...mechanical connected systems and devices used in In-Vitro... ...experience relating to electronics in medical device development and fabrication... ...safety, quality and regulatory guidelines and policies are followed... ..., refinement and consistent global implementation of electrical...Medical device$132k - $176k
...mechanical connected systems and devices associated with In-vitro... ...experience relating to firmware in medical device development and... ...applicable safety, quality and regulatory guidelines and policies are followed... ..., refinement and consistent global implementation of firmware /...Medical deviceWork experience placement$100k - $125k
...currently offer over 600 clinically relevant medical devices to healthcare providers, including... ...leading and driving all aspects of the Global Supplier Quality Management Program.... ...role ensures supplier compliance with regulatory requirements, corporate quality standards...Medical deviceRemote work- ...Location Detail St Vincents Medical Center (10427) Shift Detail Monday - Friday... ...records are maintained to meet hospital and regulatory requirements. Provides service and... ...through pre-purchase assessment of medical devices/equipment and evaluation of replacement...Medical deviceWork at officeMonday to FridayShift workNight shiftWeekend work
$140k - $165k
...over 600 clinically relevant medical devices to healthcare providers,... ...years of product management, global marketing, upstream marketing... ...partner closely with R&D, PMO, Regulatory, Quality, Service,... ...report to the Global Product Director, IVF Equipment. You will work...Medical deviceTemporary work- ...support quoting, and assist with shipping while ensuring patient and distributor satisfaction. You will communicate with patients about device usage, verify information, and support marketing and social media efforts to promote sam® technology. This role emphasizes accuracy...Medical device
$75k - $100k
...and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment... ...Periodic Safety Update Reports (PSURs) to ensure compliance with global regulatory requirements. The role collaborates cross-functionally to...Medical deviceRemote work- ...ongoing process development. Reports to Director of Manufacturing Operations... ...set up and configure personal computing devices. · Writing skills necessary to document... ...systems test experience. · Experience in Medical Device Manufacturing or other highly regulated...Medical deviceFull time
$72k - $90k
...change lives start here. Medtronic is a global leader in healthcare technology with a Mission... ...patients first — developing innovative medical technologies that improve the lives of 72... ...:Provide technical support for CRM devices and therapies by performing system checks...Medical deviceWork experience placementH1bWork at officeLocal areaRemote workFlexible hoursWeekend work$100k - $110k
...and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options... ...(Sr. BA) is a hands-on problem-solving role within the Global Supply Chain Data Analytics & Data Science team at CooperSurgical...Medical deviceFull timeInterim roleImmediate start- ...incorporating feedback Producing documentation to support medical device regulatory processes Who This Is For Students graduating in 2026... ...in diagnostics, life sciences, and biotechnology. Our global teams work every day to solve the world’s most complex challenges...Medical deviceRemote jobInternship
- ...UIL HOLDINGS CORPORATION, part of Avangrid, seeks a regulatory leader to guide Connecticut electric tariff strategy and rate design. You will lead testimony, coordinate cross-functional teams, and develop policy in rate proceedings before PURA, with emphasis on reliability...
- ...everything we do at Intuitive. As a global leader in robotic-assisted... ...safest and highest quality devices for minimally invasive... ...support requests for approval by regulatory agencies such as the FDA.Provide... ...field. Minimum 15 years of medical device experience.Proven experience...Medical deviceLocal areaWorldwideFlexible hours
$20 - $22 per hour
...is a plusPreferred ExperienceExperience inspecting precision-manufactured mechanical components in an aerospace, electronics, medical device, or other highly regulated manufacturing environment is highly desirable.Pay Details: $20.00 to $22.00 per hour Benefit offerings...Medical deviceHourly payTemporary workCurrently hiringLocal area$34 - $55 per hour
...performance of highly complex biomedical and medical imaging equipment. The individual should... ...of duties. The BMET/ISE Hybrid ensures regulatory compliance, assists in inventory... ...complete and accurate inventory of medical devices, including trial and evaluation, rental,...Medical deviceHourly payFor subcontractorWork at office- ...of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and... ...compliance by ensuring that all applicable safety, quality and regulatory guidelines and policies are followed to develop safe and effective...Medical device
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