Senior Quality & Regulatory Leader — Medical Devices
Dahl Consulting
Dahl 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 to ensure FDA/ISO compliance and drive product innovation. The ideal candidate will guide risk management, design controls, and regulatory submissions, while building a high-performing team of six. A strong history in medical devices and cross-functional collaboration is required. #J-18808-Ljbffr Dahl Consulting
- PROMED MOLDED PRODUCTS INC in Plymouth, Minnesota is seeking a Senior EHS Manager to lead the Environmental, Health & Safety strategy... ...years of progressive EHS experience, with strong knowledge of regulatory inspections and a bachelor’s degree in a relevant field. The position...SeniorRegulatoryMedical device
$80k - $120k
...in this role assists with medical writing and regulatory documentation, including preparation... ...and international medical device regulations to ensure... .... Pay Rate: $80-120k Seniority level Mid-Senior level Employment... ...Full-time Job function Quality Assurance Industries...QualitySeniorRegulatoryMedical deviceFull timeWork at office- ...verification and validation of embedded medical systems, including execution... ...documentation aligned with regulatory standards. Ensures product... ...testing for embedded medical devices Execute regression,... ...testing to ensure robust product quality Test Design & Documentation Translate...QualitySeniorRegulatoryMedical device
$130k - $160k
...forward. As a global medical technology leader for nearly 100 years,... ...Norfolk, Virginia Site Quality leader and Management... ...function a medical device design and... ...corporate objectives and regulatory requirements (QMSR, GMP... ...production employees through senior management. Must...QualitySeniorRegulatoryMedical deviceHourly payWork experience placementFlexible hours- ...Senior Project Manager – Medical Device Development Minnesota | On-Site | Permanent We are partnering with a... ...spanning R&D, electrical, software, quality, and operations, while ensuring programs... ...510(k) submission processes and regulatory milestones PMP is not required and...QualitySeniorRegulatoryMedical devicePermanent employment
- ...At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency... ...respiratory illnesses. The Senior Supplier Quality Engineer is responsible for managing... ...products and materials meet regulatory requirements and internal...QualitySeniorRegulatoryMedical deviceHourly payContract workWork experience placement
- ...join our team! ABOUT THE ROLE Senior Operations Manager We are... ...operations to meet quality, cost, and delivery targets.... ...experience, with at least 5 years in medical device leadership. Preferred... ...driven decision-maker with deep regulatory knowledge. Why Join Us Build...QualitySeniorRegulatoryMedical device
- ...Senior Systems Engineer Location: North Plymouth MN Contract... ..., and validation of medical devices. Responsibilities... ...sources such as user needs, regulatory standards, human factors, quality, manufacturing, service,... ...collaboration with project leaders Creative problem solver...QualitySeniorRegulatoryMedical deviceContract workShift work
$93.6k - $131.04k
...At Tactile Medical, we specialise in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency... ...and respiratory illnesses. The Senior Quality Engineer provides quality... ...Engineering, and Supply Chain to ensure regulatory compliance, effective risk...QualitySeniorRegulatoryMedical device$120k - $140k
SUMMARY The Quality Systems Manager is responsible for strategy, deployment, alignment... ...maintenance of the company’s notified body and regulatory agency registration processes and... ...it is associated to Class II and III medical device design, manufacturing, servicing, and distribution...QualitySeniorRegulatoryMedical deviceTemporary workLocal area$102k - $162k
...Senior Clinical Research Associate Job Description The Senior... ...ensuring adherence to ISO/FDA regulatory requirements, Good Clinical... ...optimize efficiency and data quality throughout the clinical research... ...within FDA regulated medical device/product environments, with strong...QualitySeniorRegulatoryMedical deviceRemote workWork visa$78k - $156k
...stakeholders from manufacturing, supply chain, clinical, regulatory, quality and marketing. Implements policies set by SC management to... ...and work order systems. Minimum 3 years of experience in a medical device manufacturing environment (preferred). APICS or other...QualitySeniorRegulatoryMedical deviceFor contractorsWork experience placement- ...Job Summary The Product Quality Engineer is responsible for the design, development, and management of projects for legacy medical device products. This role focuses on Design Quality activities... ...of Risk Management, C&PA, and regulatory requirements such as FDA QSR, ISO 13...QualitySeniorRegulatoryMedical deviceFlexible hours
- ...morning progresses, you may review Device History Records for... ...Throughout the day, you trend key quality metrics for your area,... ...meticulous records that stand up to regulatory scrutiny. Schedule 6:00am... ...Quality Inspector experience in medical device manufacturing or...QualitySeniorRegulatoryMedical deviceTemporary workMonday to FridayDay shift
$170k - $180k
Title: Senior Manager of Quality and Regulatory Location: Plymouth, MN Job Type: Permanent Compensation: $... ...000 - $180,000 + Bonus Industry: Medical Device and Healthcare Technology About The... ...a collaborative and influential leader who can effectively partner across...QualitySeniorRegulatoryMedical devicePermanent employmentFlexible hours$78k - $156k
...Employees can qualify for free medical coverage in our Health... ...manufacturing process of a medical device and understand and develop... ...to maintain microbiological quality of the final device. What You... ...for ethylene oxide cycles per regulatory requirements. Knowledge and ability...QualitySeniorRegulatoryMedical deviceFor contractorsWork experience placementWorldwide$105.87k - $158.8k
...Senior Quality Engineer Location: Minneapolis, MN, US... ...improvements and processes to ensure regulatory compliance and promote... ...and Wellness :Comprehensive medical, dental, and vision insurance... ...the world s leading medical device companies. We are constantly...QualitySeniorRegulatoryMedical deviceImmediate startFlexible hours$100.27k - $162.29k
...Senior Biostatistician Location: Minneapolis... ...clinical research, regulatory submissions, and... ...Process Development, Quality, and Operations. The role... ...clinical scientists, medical affairs, and regulatory... ...experience in medical device, pharmaceutical, biotechnology...QualitySeniorRegulatoryMedical deviceContract workImmediate startFlexible hours$113.3k - $226.7k
Senior Product Manager, Global Upstream Marketing -... ...is a global healthcare leader that helps people live... ...in diagnostics, medical devices, nutritionals and branded... ...restore health and improve quality of life by designing... ..., Medical Affairs, Regulatory, Health Economics, Operations...QualitySeniorRegulatoryMedical device$120k - $134k
Position Summary The Senior Project Manager will lead cross‑functional... ...products meet customer, regulatory, and business requirements.... ..., particularly in medical devices, and a background in new product... ...and coordination across R&D, Quality, Regulatory, Marketing, and...QualitySeniorRegulatoryMedical deviceTemporary workFor contractorsLocal area- ...technology company is seeking a Senior Program Manager in Minnetonka, MN... ...role requires an experienced leader to oversee complex projects in the medical device sector. You will manage project... ...while ensuring compliance with regulatory standards. Candidates should possess...SeniorRegulatoryMedical deviceFull time
$16.2 - $32.4 per hour
...Senior Operator In Abbott's Electrophysiology (... ...through breakthrough medical technologies in atrial... ...Performs regular process and quality performance audits of... ..., and process medical devices and related parts... ...Systems (EMS), and other regulatory requirements....QualitySeniorRegulatoryMedical device- ...commercial and non-commercial finished medical devices. Primary responsibility for this role will... ...to achieve production goals. Build Quality into all aspects of their work by... ...internal procedures, customer alignment and regulatory acceptance requirements provided....QualitySeniorRegulatoryMedical deviceImmediate start
$19.83 - $29.09 per hour
...Senior Machine Operator The primary purpose of the Senior Machine... ...environmental, security and quality requirements including, but... ...procedures, and other regulatory requirements. Operates machinery... ...manufacturing environment; medical device experience preferred....QualitySeniorRegulatoryMedical deviceWork experience placementImmediate startMonday to ThursdayShift workDay shift$115.5k - $169.4k
...Senior Process Development Engineer Integer is a... ...providing innovative, high-quality technologies and manufacturing to Medical Device OEM's (original... ...procedures, and other regulatory requirements. You will... ...activities and deployment of Leader Standard Work....QualitySeniorRegulatoryMedical deviceImmediate startWorldwide$127.93k - $176.55k
...Annually POSITION SUMMARY The Senior EHS Manager is responsible... ...cross-functionally with Quality, Engineering, Facilities, and... ...limited to the following: Regulatory Compliance & Governance Ensure... ...continuity plans. Cleanroom & Medical Device Manufacturing Support...QualitySeniorRegulatoryMedical deviceLocal area- ...Neurotech LLC in Plymouth, MN, is seeking a Quality Affairs Lead to develop a scalable Quality Management System critical for the regulatory success of its Class III... ...demands over 10 years of experience in medical device quality, deep knowledge of regulatory requirements...QualityRegulatoryMedical device
$21.55 - $43.05 per hour
...Abbott is a global healthcare leader that helps people live more... ...products in diagnostics, medical devices, nutritionals and branded generic... ...developing and maintaining quality engineering methodologies... ...Management Systems (EMS), and other regulatory requirements. Complies...QualitySeniorRegulatoryMedical deviceHourly payFor contractorsWork experience placementWorldwide- B Capital in Maple Grove, Minnesota, is seeking a Principal Regulatory Affairs Specialist to join their Interventional Oncology and Embolization team. This role is responsible for planning and managing regulatory submissions to FDA and EU, supporting new product development...SeniorRegulatoryMedical deviceWork at office3 days per week
- Adraxe Corporation seeks a Quality Affairs Lead to build and own a lean QMS enabling the transition from early clinical success to full... ..., and risk management across development, audits, and regulatory submissions, coordinating with Engineering, Clinical, and Regulatory...QualityRegulatoryMedical device
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