Senior Regulatory Affairs Lead - Medical Devices
Boston Scientific Corporation
Boston Scientific in the United States is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for innovative medical devices. You will plan and manage submissions to the FDA, EU notified bodies and other international authorities, and collaborate with cross-functional teams. The role requires 5+ years in regulatory affairs, strong writing and editing skills, and experience with PMAs, 510(k)s, and MDR technical documentation. #J-18808-Ljbffr Boston Scientific Corporation
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Lead - Medical Devices in Osseo, MN vacancy
- Nextern in Maple Grove, MN, is seeking a Medical Device Assembler III to maintain manufacturing processes, monitor quality and yields, and train team members. The role may require stepping in as supervisor and fostering high-functioning teams. Success hinges on lean manufacturing...SeniorMedical device
- Boston Scientific Corporation seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for new and modified medical devices and to shape regulatory strategies across domestic and international markets. You will collaborate with cross-functional teams...SeniorMedical device
- Boston Scientific seeks an experienced Regulatory Affairs Fellow to provide strategic leadership in navigating the U.S. medical device regulatory landscape and strengthen relationships with European Notified Bodies. The role partners across Regulatory Affairs, Quality,...Medical device
- Boston Scientific in Maple Grove, MN seeks a Senior R&D Manager to lead the development of next-generation interventional cardiology devices within the Emerging Technologies Division. You will guide a talented engineering team to deliver innovative cardiac pumps and heart...SeniorMedical device
- HistoSonics, Inc. is seeking a Contract Senior Recruiter to own full life cycle recruiting across multiple functions in a high-growth medical device company. The role partners with hiring managers and HR to attract, assess, and hire top talent while delivering an exceptional...SeniorMedical deviceContract workWork at office3 days per week
$89.2k
...business provides proven, leading solutions to treat several... ...surgical procedures. As a Senior Regulatory Affairs Specialist , you will... ...positive relationships with device reviewers through oral and... ...related discipline within the medical device industry, including...SeniorMedical deviceHourly payWork at officeLocal areaShift work3 days per weekBoston Scientific Corporation
Maple Grove, MN12 hours ago- ...Senior Quality Systems Engineer The Senior Quality Systems Engineer... ...compliance with applicable regulatory requirements and industry... ...responsibilities include: Lead and support QMS processes... ...3+ years of experience in a medical device manufacturing, quality or regulatory...SeniorMedical deviceWork at office3 days per week
Intracept by Boston Scientific
Maple Grove, MN2 days ago - ...and peripheral catheter platforms. The Senior Regulatory Affairs Specialist will provide regulatory... ...Design Assurance, Quality, Clinical, Medical Safety, Operations, Service, and international... ...for regulatory readiness, including device descriptions, architecture and...SeniorMedical deviceHourly payWork at officeLocal areaShift work3 days per week
Boston Scientific Corporation
Maple Grove, MN3 days ago - ...Engineer in Plymouth, MN. This expert-level role leads design assurance strategy across the medical device portfolio, with emphasis on IEC 62304 software, working... ...and launch plans. You will partner with Regulatory, R&D, and Product Development, define verification...SeniorMedical device
- ...Job Description Job Description Summary: We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. Roles & Responsibilities: ~10+ years of Quality Engineering experience in medical device...SeniorMedical deviceContract work
Katalyst Healthcares & Life Sciences
Champlin, MN19 days ago $129.3k - $258.7k
...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and... ...than 160 countries. Senior Manager Quality Compliance... ..., audit readiness, regulatory change management,... ...Manufacturing, Regulatory Affairs, Supply Chain, and...SeniorMedical deviceWorldwide- Laborie is seeking a Senior R&D Project Manager in Minnesota to lead new product development from concept to commercialization, oversee design transfer, and integrate products into QMS and regulatory frameworks. You will coordinate cross-functional teams across engineering...SeniorMedical device
- ...Supervisor with a strong technical foundation to lead laboratory operations in a fast-paced medical device environment. You will oversee capabilities, resource... ...product development, design verification testing, regulatory submissions, and other R&D initiatives, while...Medical device
$85k - $110k
...Description Job Description A medical manufacturing client in New... ...is looking to hire a senior quality engineer to join their... ...Class II or Class III medical device contract manufacturing complex... ...Day To Day: Support and/or lead Qualification activities required...SeniorMedical deviceContract workCypress HCM
New Hope, MN29 days ago$110k - $130k
...Senior Validation EngineerFull-time, on-site position. Core office... ...Engineer is responsible for leading validation strategy,... ...in regulated environments (medical device, pharmaceutical, or similar)... ...validation methodologies and regulatory requirements· Customer/Client...SeniorMedical deviceWork at officeMonday to FridayDelta Industrial Services, Inc.
Anoka, MN3 days ago- ...Senior Quality Systems Engineer Work mode: Hybrid Onsite Location... ..., ensuring compliance to Medical Device regulations and BSC Quality... ...global, systemic CAPAs while leading through a Community of Practice... ...and anticipates emerging regulatory lines of questioning Supporting...SeniorMedical deviceWork at officeLocal areaRelocation package3 days per week
Boston Scientific
Maple Grove, MN2 days ago $100k - $140k
Software Test Engineer / Senior Software Test Engineer / Principal Software Test EngineerA growing and innovative medical device organization is seeking Software Test Engineers at... ...test automation practices, supporting regulatory compliance efforts, and collaborating...SeniorMedical deviceReal Staffing Group
Minneapolis, MN12 hours ago$51 - $89 per hour
...documentation, and collaboration tools. Preferred Skills Experience in a regulated environment, ideally with software as a medical device (SaMD). Background supporting SOC 2 audit readiness, evidence collection, control testing, or remediation. Experience...SeniorMedical deviceHourly pay- A leading medical device firm is seeking a Mechanical Engineering Technician/R&D Lab Lead to provide technical expertise in R&D labs. Responsibilities include supporting project teams in device development, managing 3D printing resources, and ensuring lab safety and compliance...Medical deviceFull time
- Arctic Cat is seeking a Senior Payroll Specialist to join our Human Resources team. You will oversee full-cycle payroll across multiple locations, ensuring accuracy, compliance, and timely delivery while partnering with HR, Finance, and employees. The role requires 5+...Senior
- ...Senior Clinical Research CoordinatorWe believe that great healthcare is an essential safeguard... ...operational efficiency and quality.Lead end-to-end TMF strategy and execution... ...administration, or related experience; medical device, pharmaceutical, or biotechnology industry...SeniorMedical deviceContract workWork at officeFlexible hours
Laborie Medical Technologies
Maple Grove, MN2 days ago - ...member of the Category team, the Category Lead is responsible for developing and... ...Operations, Engineering, R&D, Quality, Finance, Regulatory, Manufacturing, and Supply Chain... ...professional certification. Experience within medical device, life sciences, healthcare,...Medical deviceContract workFlexible hours
$25 - $32 per hour
...445 About us: For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions... ...experience in leading team performance and regulatory compliance. Shift Hours: 1st shift; 5:00AM -...Medical deviceHourly payContract workAll shiftsShift workDay shift- ...Job Description Job Description A medical device client is hiring a permeant Sr. Regulatory Specialist, onsite in Maple Grove, MN. This person will assist... ...filings, review of marketing materials, etc. This Senior Regulatory Specialist will play a key role in ensuring...SeniorMedical deviceWork at office
- Jabil is seeking a Quality Engineer II to ensure product quality and process compliance in medical device manufacturing. You will apply engineering principles and quality tools to drive continuous improvement and robust quality systems. The role supports R&D, manufacturing...Medical device
- ...a key member of the R&D team, the Senior R&D Project Manager will lead the planning and execution of new... ...alignment, manages technical and regulatory complexity, and ensures disciplined... ...in highly regulated environments - medical device, combo device, life sciences, aerospace...SeniorMedical deviceContract workFlexible hours
- Integer seeks a seasoned Technical Sales professional to lead technical discussions, identify new business opportunities, and promote our capabilities to drive revenue and profit growth. You will coordinate with Global Accounts, quoting teams, and manufacturing to scope...SeniorMedical device
- ...technical sales leader to drive revenue growth by leading technical discussions and promoting our supply chain solutions to medical device customers. You will collaborate with R&D,... .... The role requires strong communication, regulatory familiarity, and the ability to travel...SeniorMedical device
$125k - $150k
...Senior Account Executive Enlil, a Shifamed portfolio company, is an AI-powered, cloud... ...is home to a dense concentration of medical device companies, including many mid-size and... ...and comfort selling software to quality, regulatory, or R&D stakeholders. ~ Experience...SeniorMedical deviceFull timeWork experience placement$125.8k
...ambitions. About the role: The Senior Marketing Manager is... ..., Data and Analytics, Legal, Regulatory, Compliance, Finance, and clinical... ...bottom-line business objectives. Lead downstream go-to-market... ...communication, and influence skills. Medical device product launch experience....SeniorMedical deviceHourly payWork at officeLocal areaRelocation packageShift workBoston Scientific
Maple Grove, MN1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Lead - Medical Devices. Be the first to apply!
Related searches
- senior manager legal Osseo, MN
- senior performance engineer Osseo, MN
- senior consulting engineer Osseo, MN
- senior performance tester Osseo, MN
- senior Osseo, MN
- senior customer success engineer Osseo, MN
- senior manager diversity & inclusion Osseo, MN
- senior collaboration engineer Osseo, MN
- senior cloud network engineer Osseo, MN
- senior application security Osseo, MN