Senior Regulatory Affairs Strategist, Medical Devices
Boston Scientific Corporation
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 to ensure compliance and timely approvals, guiding labeling, changes, and audit readiness. The role requires 5+ years in regulatory affairs, a Bachelor's degree, and proficiency with PMA/510(k) and EU MDR documentation. #J-18808-Ljbffr 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...SeniorMedical device
$89.2k
...urology surgical procedures. As a Senior Regulatory Affairs Specialist , you will provide Regulatory... ...positive relationships with device reviewers through oral and written communications... ...or a related discipline within the medical device industry, including R&D,...SeniorMedical deviceHourly payWork at officeLocal areaShift work3 days per week- ...Senior Quality Systems Engineer The Senior Quality Systems Engineer provides technical... ...), ensuring compliance with applicable regulatory requirements and industry standards.... ...degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/...SeniorMedical deviceWork at office3 days per week
- ...employees experience every day.The Senior Manager, Clinical Real-World Evidence (RWE) Strategist, Epidemiology serves as a... ..., partnering with Clinical, Regulatory, R&D, Medical Affairs, Marketing, HEMA, HEOR, and... ...Scientific, supporting device development, post-market evidence...SeniorMedical deviceHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week
- ...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
- 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
- ...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
- 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
$129.3k - $258.7k
...and products in diagnostics, medical devices, nutritionals and branded... ...in more than 160 countries. Senior Manager Quality Compliance Working... ..., audit readiness, regulatory change management, field actions... ..., Manufacturing, Regulatory Affairs, Supply Chain, and Commercial...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
- ...Quality Systems EngineerAbout the role:The Senior Quality Systems Engineer provides... ...), ensuring compliance with applicable regulatory requirements and industry standards.This... ...degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/compliance...SeniorMedical deviceHourly payWork at officeShift work3 days per week
$85k - $110k
...Job Description Job Description A medical manufacturing client in New Hope, Minnesota is looking to hire a senior quality engineer to join their team. This Sr Quality... ...experience with Class II or Class III medical device contract manufacturing complex catheters and...SeniorMedical deviceContract work$110k - $130k
...Senior Validation EngineerFull-time, on-site position. Core office hours are Monday... ...teamsExperience working in regulated environments (medical device, pharmaceutical, or similar)... ...expertise in validation methodologies and regulatory requirements· Customer/Client Focus...SeniorMedical deviceWork at officeMonday to Friday- ...Senior Quality Systems Engineer Work mode: Hybrid Onsite Location(s): Arden Hills, MN... ...controls processes, ensuring compliance to Medical Device regulations and BSC Quality System... ...company level and anticipates emerging regulatory lines of questioning Supporting both site...SeniorMedical deviceWork at officeLocal areaRelocation package3 days per week
$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 device$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- ...’re Looking For: As a key member of the Clinical team, the Senior Clinical Research Coordinator services as an experienced clinical... ...management, contract administration, or related experience; medical device, pharmaceutical, or biotechnology industry experience...SeniorMedical deviceContract workWork at officeFlexible hours
- ...employees experience every day.The Senior Clinical Education Strategist will develop and execute innovative... ...work collaboratively with clinical, medical, scientific, marketing, research and... ...cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose...SeniorHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week
- ...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
- ...: As a key member of the R&D team, the Senior R&D Project Manager will lead the planning... ...alignment, manages technical and regulatory complexity, and ensures disciplined cross... ...Experience in highly regulated environments - medical device, combo device, life sciences, aerospace...SeniorMedical deviceContract workFlexible hours
- ...technical discussions and promoting our supply chain solutions to medical device customers. You will collaborate with R&D, product development... ...proposals. The role requires strong communication, regulatory familiarity, and the ability to travel regionally. #J-18808-...SeniorMedical device
$68.5 per hour
...Senior Packaging Acquisition Engineer (Contract | 6-Month Assignment) Lead Critical Packaging Integration Projects Are you an... ...~ Experience in a regulated industry preferred, including medical device, pharmaceutical, or advanced manufacturing environments ~...SeniorMedical deviceContract workFor contractorsLocal areaImmediate startVisa sponsorship- 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
$125.8k
...whatever your ambitions. About the role: The Senior Marketing Manager is responsible for... ...Operations, Data and Analytics, Legal, Regulatory, Compliance, Finance, and clinical... ..., communication, and influence skills. Medical device product launch experience. Proven ability...SeniorMedical deviceHourly payWork at officeLocal areaRelocation packageShift work$131k - $151k
...valve. Anteris is seeking a Senior Usability / Human Factors... ...across functions to develop device design, packaging, labeling,... ...ensuring compliance with ISO and regulatory standards (e.g., FDA Human... ...in usability engineering for medical devices. Experience with interventional...SeniorMedical deviceTemporary workH1bLocal areaVisa sponsorshipWork visaFlexible hours$55 - $75 per hour
...Job Description Job Description Senior R&D Engineer – Medical Device Engineering Location: Plymouth, MN 55441 Duration: 12-Month Contract... ...while ensuring products continue to meet rigorous regulatory, manufacturing, and quality standards. You'll collaborate...SeniorMedical deviceLong term contractFull timeContract workFor contractorsLocal area- 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
- Viltis, a global diagnostics organization, seeks a detail-oriented Regulatory Affairs Specialist I to support regulatory submissions, product registrations, and quality management for IVD products in South Portland, Maine. The role focuses on domestic and international...Medical device
$110k - $150k
About Inspire Medical Systems Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive... ...time off (FTO), and tuition reimbursement. The Senior Regulatory Affairs Specialist will lead and execute regulatory...SeniorMedical deviceWork experience placementLocal areaFlexible hours
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