Director, Regulatory Affairs & Quality - Medical Devices
Sway
Eight Sleep is seeking a Director of Regulatory Affairs and Quality Assurance to lead risk management and oversee the quality management system. You’ll serve as primary liaison with regulatory agencies and collaborate closely with R&D, Clinical, and the executive team. The role is rooted in San Francisco. You’ll drive regulatory submissions, ensure compliance with ISO 13485 and ISO 14971, and shape the company’s path to FDA clearances while advancing patient safety and product quality. #J-18808-Ljbffr Sway
- Alltrista Plastics LLC in Greer, SC, USA seeks a Director of Quality Systems and Regulatory Affairs to lead global regulatory strategy and QMS implementation... ...role requires a strategic leader with 10+ years in medical device QA/RA, proven submissions experience, and strong...QualityMedical device
- Job Title: Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos: Pelthos... ...and industry standards, are high quality, consistent, and complete. Essential... ...of other medicinal products such as medical device requirements. Ability to think strategically...QualityMedical deviceWork at officeLocal area
$149.3k - $298.7k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...THE OPPORTUNITY: The function of a Director, Regulatory Affairs is to combine scientific, regulatory... ...them based on regulatory changes. Set quality and accuracy standards. Anticipate...QualityMedical deviceWorldwideShift work- Alltrista - Director, Quality Systems & Regulatory Affairs Greer, SC, USA Job Description Alltrista Plastics LLC,... ...markets include Consumer Products, Medical/Healthcare, Personal Care, Health... ...Regulatory Affairs within the medical device industry. In-depth knowledge of...QualityMedical deviceWorldwide
- ...to leverage our Pod platform to detect medical conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a business... ...experience in quality functions for medical devices Successful track record of FDA...QualityMedical deviceFull timeImmediate startWorldwideFlexible hoursNight shift
- Insightecis a growing medical technology company transforming patient... ...Patients, Integrity, Team, Quality and Innovation. Our... ...and maintenance of clinical regulatory submissions of INSIGHTEC products... ...Establishment Registrations, Device Listing, and other pertinent...QualityMedical deviceFlexible hours
- A growing technology-driven medical device manufacturer is seeking a Manufacturing Quality Director with extensive experience in overseeing quality functions and ensuring regulatory compliance. This role will lead initiatives in catheter assembly processes and drive quality...QualityMedical device
$154.4k - $231.6k
## Responsable sr des Affaires réglementairesPostulerremote type:... ...ée type** **Senior Manager, Regulatory Affairs Operations & Technical... ...team.* Oversee the medical device data management for global Unique... ...regulatory requirements and quality systems.* Experience leading...QualityMedical deviceTemporary workH1bLocal areaImmediate startWorldwide$170k - $185k
...Join our mission as our next Senior Regulatory Affairs Manager. This role manages regulatory... ...approval of new in vitro diagnostics and medical devices into the worldwide market, as... ...regulatory agencies. Advanced knowledge of quality systems and good manufacturing...QualityMedical deviceWork experience placementWork at officeLocal areaRemote workWorldwideHome officeNight shift$110k - $135k
MANAGER, QUALITY & REGULATORY AFFAIRS The Quality & Regulatory Affairs Department provides... ...oversight for Integrated Medical Systems' quality systems,... ...Reporting directly to the Director of Biomedical Operations,... ...healthcare distribution, medical devices, pharmaceuticals, or...QualityMedical deviceContract workWork at office- ...automation, air and water quality environmental monitoring... ...and production, medical imaging and pharmaceutical... ...13485:2016, applicable regulatory requirements, and EU Medical Device Regulation (MDR) 2017/74... ...Engineering, Quality, Regulatory Affairs, Life Sciences,...QualityMedical devicePermanent employmentWork experience placementLocal area
- ...Vonco Products, LLC in Kentucky is seeking a hands-on Quality Manager to lead our ISO 13485 Quality Management System within a fast-paced medical device packaging operation. You will partner with Operations, Engineering, Supply Chain and Customer Service to ensure compliance...QualityMedical device
- Medline Industries, LP in Chicago, IL seeks a Quality Engineer/Engineer who will independently set basic quality standards for in-process activities and lead efforts to test, sample, and train. You will evaluate production processes and drive improvements while managing...QualityMedical device
- Marmon Holdings, Inc. through MicroAire Surgical Instruments LLC is seeking a Principal Quality Assurance Engineer. This senior role leads QA for new medical devices and supports existing products, coordinating CAPA, audits, and supplier quality while mentoring QA staff...QualityMedical device
- ...want you to have: ~5+ years of demonstrated experience in medical device company ~ Solid experience in crafting reports and... ...multitasking skills to improve productivity ~ Demonstrated commitment to open and clear communication, team building, and quality...QualityMedical device
- Cretex Medical is a leading contract manufacturer serving the medical device industry, offering precision components and assemblies. The Quality Engineer will define, implement, and improve quality... ..., and quality teams to ensure regulatory compliance and #J-18808-Ljbffr...QualityMedical deviceContract work
$85k - $95k
...Engineer, Reliability to join the Hardware Development Team. The role plans and contributes to reliability activities to meet safety, quality, and business goals, testing and validating hardware and software reliability in a regulated environment. The position is hybrid...QualityMedical device3 days per week- ...Validation Engineer to lead validation studies for reusable medical devices, including cleaning, sterilization, and reprocessing... ...develop test methods and analyses, and collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure compliant product launches. Requirements...QualityMedical device
- Aurora Lifesciences seeks a hands-on Quality Engineer at our precision medical device manufacturing site in the United States. You’ll be on the shop floor... ...and Supply Chain to ensure products meet regulatory and customer standards. You will investigate issues,...QualityMedical device
- Freudenberg Group is seeking a senior quality leader to oversee inspection functions in the Quality department, directing workload and ensuring adherence to medical device standards. The role includes training inspectors, maintaining timecards, and ensuring standard work...QualityMedical device
- ...Position Overview: The quality assurance specialist assists in ensuring that medical devices meet established quality standards and regulatory requirements. This role involves supporting quality assurance activities, quality management systems, R&D and design control processes...QualityMedical device
- ...will coordinate and review activities to ensure adherence to global standards, regulations, and the Merz Quality System. The role requires 3-5 years in quality within medical devices/pharma, plus 2+ years in a supervisory capacity. #J-18808-Ljbffr Merz North America, Inc.QualityMedical device
- ...LLC in Charlottesville, VA seeks a Principal Quality Assurance Engineer to lead quality activities for new medical devices and ongoing support of existing products. You... ...operations. You will ensure compliance with regulatory requirements, perform advanced statistical analyses...QualityMedical device
- TekniPlex is hiring an Operations Quality Engineer for our Clayton, NC facility. This role ensures product quality and regulatory compliance within the manufacturing environment, including FDA 21 CFR Part 820 and ISO 13485. You will support production operations by managing...QualityMedical device
- ...plc is seeking a Senior Risk Management Quality Engineer to lead risk management... ...focuses on risk analysis, design controls, regulatory compliance, and patient safety across the... ...has strong risk management experience in medical devices, ability to mentor teams, and a track...QualityMedical device
- ...Engineer in Kentucky to lead validation efforts for reusable medical devices. You will develop and execute validation studies, create... ..., perform root cause analyses, and collaborate with R&D, Quality, Regulatory, and manufacturing to ensure regulatory compliance and successful...QualityMedical device
- Millstone Medical Outsourcing is a fast-growing provider specializing in sterile/non-sterile packaging and related services. The Process... ...equipment, and support improvements while ensuring high quality and efficiency. The role requires a Bachelor’s Degree in engineering...QualityMedical device
- ...equipment for Masimo products. This on-site role focuses on data-driven improvements that enhance quality, efficiency, and manufacturability while complying with regulatory requirements. The position supports new product introductions and sustaining manufacturing...QualityMedical device
$235k - $288.75k
...We are seeking an experienced Senior Director, Regulatory Affairs, to lead our regulatory strategy and... ...with regulatory agencies, supervising quality assurance, and addressing regulatory... ...~401k plan with company matching ~ Medical (premiums covered by Eikon at 95%), dental...QualitySummer holidayWork at office3 days per week- ...Tremendous opportunity for an experienced Quality Manager to join this established and... ...guide quality personnel, take ownership of regulatory and compliance quality related matters... ...aerospace, automotive, semiconductor, medical device or similar) Strong knowledge of Six...QualityMedical deviceRelocation package
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