Quality Affairs Lead, Medical Devices (Class III)
Blackrock Neurotech
Adraxe Corporation is seeking a Quality Affairs Lead to build a lean QMS and own design controls for a Class III implantable neurostimulation system. The role focuses on DHF integrity, regulatory readiness, and risk management across development and clinical activities, coordinating with external partners to accelerate product development. The successful candidate will drive IDE/PMA readiness, supplier qualification, and inspection readiness while enabling scalable quality operations and team #J-18808-Ljbffr Blackrock Neurotech
- Adraxe Corporation is an innovative medical device startup focused on the design, development... ...with epilepsy. The Role The Quality Affairs Lead exists to build and own a lean, scalable... ...development and commercialization of its Class III implantable neurostimulation system....QualityMedical device
- ...As a Regulatory Affairs Specialist, you will drive hands‑on... ...regulations and corporate quality standards. Strategic Planning... ...with applicable medical device advertising regulations. Regulatory... ...knowledge of global Class I, II, and/or III medical device requirements...QualityMedical device
- ...Regulatory Affairs Specialist II - (RAS2.1) Company Description... ...years’ experience in regulated medical device industry highly preferred. Knowledge of global Class I, II and/or III hardware/software/sterile... ...Extensive knowledge of global quality system requirements...QualityMedical deviceWork at office
$45 - $55 per hour
job summary: Join a leading global life sciences and filtration... ...are seeking a Regulatory Affairs Specialist III to lead global compliance... ...filtration, bioprocessing, or medical device products. Deep knowledge... ...ISO 9001 and ISO 13485 quality management systems. #LI...QualityMedical deviceHourly payContract workTemporary workWork experience placement- ...Regulatory Affairs Specialist III | Maplewood, Minnesota, United States... ...Product Stewardship • Lead product stewardship activities... ...Research & Development • Quality • Manufacturing • Operations... ..., diagnostics, medical device, pharmaceutical, or chemical...QualityMedical deviceMonday to FridayFlexible hours
- Boston Scientific is hiring a Principal Regulatory Affairs Specialist in Maple Grove, MN, to lead regulatory strategy for a broad ablation portfolio. The... ...s, and EU MDR submissions, collaborating across R&D, Quality, Operations and Clinical teams, and engaging with FDA...QualityMedical device
- ...Regulatory Affairs Specialist III – Maplewood, MN (Hybrid) Contract Duration... ...applicable. Product Stewardship Lead product stewardship... ...with Research & Development, Quality, Manufacturing, Operations,... ...bioprocessing, diagnostics, medical device, pharmaceutical, or chemical...QualityMedical deviceContract work
$92k - $138k
...Senior Regulatory Affairs Specialist Careers... ...innovative medical technologies that... ...independence, and quality of life. At Medtronic... ...high-risk medical device portfolio. Role... ...strategies and leads worldwide submissions... ...~ Experience with Class III medical devices (...QualityMedical deviceH1bWork at officeLocal areaWorldwideFlexible hours- ...organization. About The Role Lead the development and execution... ...ensuring alignment with technical, quality, and commercial requirements.... ...tools. Understanding of medical devices and industry regulations.... ...everyday is to operate as a world-class specialist medical company...QualityMedical deviceContract workFlexible hours
- ...Vice President of Quality Assurance About the Company... ...cardiovascular medical device company with commercial... ...and a strong focus on Class II/III devices, particularly... ...ability to build and lead high-performing quality... ...including regulatory affairs, clinical affairs, R&D...QualityMedical device
$45 - $55 per hour
...Regulatory Affairs & Product Stewardship Specialist Adecco... ...Life Sciences is supporting a leading global life sciences... ...compliance, chemical regulations, quality systems, or related technical... ...bioprocessing, diagnostics, medical device, or chemical products. Knowledge...QualityMedical deviceHourly payContract workTemporary workLocal areaMonday to FridayFlexible hours- Boston Scientific Gruppe is seeking a Regulatory Affairs professional to join their Interventional Oncology and Embolization team... ...regulatory strategies and managing submissions for Class II medical devices, ensuring compliance with both US and EU regulations. The ideal...Medical device
$53.6k - $80.4k
...Team Lead IV At Medtronic, we act boldly, compete to win, move... ...area, ensuring safety, quality, and efficiency standards are... ...role within a manufacturing or medical device environment Experience with... ...requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required. Physical...QualityMedical deviceWork experience placementH1bWork at officeLocal areaImmediate startFlexible hoursAfternoon shift$35.7 per hour
...Repair Technician III Your Work Shapes the World... ...products, best in class solutions or creating... ...over 100-year legacy of quality and innovation and 150... ...Experience coordinating or leading repair/rework... ...magnets that may impact medical devices. Kneel, squat, and crawl...QualityMedical deviceWeekly payPart timeRelocation packageMonday to FridayFlexible hoursShift workDay shift- ...Medical Device III Software Engineer (Minneapolis, MN) Job Description This position is responsible... ...code reviews, and testing. • Conduct, lead, and participate in code and design... ...physician in service programs. • Maintain Quality System compliance in coordination with...QualityMedical deviceHourly payContract workTemporary workImmediate startRelocationWork visa
- ...About The Role Perform Quality activities associated with cGMP biologics, intermediate... ...+ years' experience in Regulated (food, medical device, or pharma/biotech) industry. Must... ...novel specialty pharmaceuticals and best in class patient support programs. Takeda is a...QualityMedical deviceFull timeWork at officeLocal areaShift workNight shiftRotating shift
$25.4 per hour
...groundbreaking products, best in class solutions or creating a... ...Caterpillar. With a 100-year legacy of quality and innovation and 150... ...As a Material Handling Team Lead, you will provide leadership... ...Exposure to magnets that may impact medical devices Kneel, squat, and crawl on...QualityMedical deviceHourly payWeekly payPart timeRelocation packageMonday to FridayFlexible hoursShift workAfternoon shift$220k - $225k
...VP Global Quality and Regulatory Trelleborg Medical Solutions is seeking a VP... ...autonomy and support to lead the production... ...of life-saving devices. Growth and advancement... ...landscape for class I, II & III productions, in a... ...and/or Regulatory Affairs Certification (RAC...QualityMedical deviceFixed term contract$170k - $180k
...: Senior Manager of Quality and Regulatory Location... ...+ Bonus Industry: Medical Device and Healthcare... ...Assurance, and Regulatory Affairs across the... ...This individual will lead a high-performing team... ...). Experience with Class II and/or Class III medical devices. Experience...QualityMedical devicePermanent employmentFlexible hours- ...Quality Engineer III Direct Hire Onsite 4 days a week The Quality Engineer III will be... ...Quality) QE BOK (Body of Knowledge) • Lead and participate in large company projects... ...the company Quality System, ISO, and medical device requirements • Read, understand, and...QualityMedical deviceTemporary workWork at office
- ...Consulting seeks a Senior Manager of Quality and Regulatory in Plymouth, MN. This role leads Quality Systems, Design Assurance, and Regulatory Affairs, reporting to executive leadership... ...team of six. A strong history in medical devices and cross-functional collaboration...QualityMedical device
- ...Plymouth, MN is seeking a strategic NPI Project Sourcing Lead to drive the launch of a next‑generation ablation catheter within the Electrophysiology Medical Device Division. You will collaborate with R&D, engineering, quality, and global suppliers to source critical...QualityMedical device
$102.1k - $194k
...seeking a Regulatory Affairs Principal to support the... ...materials for medical devices used in interventional... ...materials. Establish and lead advertising and promotional... ..., Clinical, Legal, Quality, Compliance, and Product... ..., or any other protected class. #J-18808-Ljbffr...QualityMedical deviceWork at office- ...Director, Regulatory Affairs – Pulsed Field Ablation... ...PFA) is responsible for leading global regulatory... ...closely with R&D, clinical, quality, medical safety, operations,... ...the regulated medical device industry, including clinical... ...any other protected class. Please be advised...QualityMedical deviceWorldwide
- ...sector is seeking a Receiving Inspection Lead to oversee the evaluation and... ...members, and maintaining the integrity of quality processes that directly impact product performance... ...a regulated manufacturing environment, medical device preferred Prior experience in a...QualityMedical deviceFull time
- ...their talent needs with high quality IT resources through Staff Augmentation... ...Value Added Services through CLASS (Competency Leveraged Advanced... ..., holidays, personal days, Medical, Dental and Vision insurance,... ...activities on medical device/equipment products and improvements...QualityMedical devicePermanent employment
$102.1k - $194k
...Responsibilities Represent the Regulatory Affairs function on cross‑functional... ...and prepare submissions for Class II medical devices. Create innovative... ...in collaboration with R&D, Quality, Operations, Medical Safety... ...updates to filings. Lead interactions with the U.S. FDA...QualityMedical deviceWork at officeLocal areaOverseas3 days per week$100k - $117k
...Product Engineer III Permanent About... ...Helping hearts beat with medical innovations? Or breathing... ...life-changing medical devices to market through... ...Product Engineer III is to lead design and development... ...decisions critical to quality on design, concept selection...QualityMedical devicePermanent employmentFull timeWorldwide- ...Job Title: R&D Engineer III Duration:12 Months Location... ...design of complex implantable medical device systems by developing system... ...system change analysis within our quality system Writing reports for... ...and standards relevant to class II/III medical devices ~...QualityMedical deviceContract workShift workDay shift
$94k - $150k
...Senior Regulatory Affairs Specialist, Ultrasound The Senior Regulatory... ...of Conformity, and Medical Device Licenses—for various global markets... ...to existing products. Lead global regulatory intelligence... ...everywhere has access to the quality healthcare that we all deserve...QualityMedical deviceFull timeWork at officeLocal areaWork visaRelocation package3 days per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Affairs Lead, Medical Devices (Class III). Be the first to apply!
- quality facilitator Minneapolis, MN
- quality assurance quality control engineer Minneapolis, MN
- quality improvement nurse Minneapolis, MN
- quality Minneapolis, MN
- quality lead Minneapolis, MN
- quality distribution Minneapolis, MN
- quality coach Minneapolis, MN
- air quality Minneapolis, MN
- quality equipment Minneapolis, MN
- water quality scientist Minneapolis, MN

