Senior Regulatory Affairs Lead, Medical Devices
Boston Scientific - Minnetonka
Boston Scientific is seeking a Principal Regulatory Affairs Specialist to support regulatory compliance across post-market activities in the Interventional Oncology and Embolization division. The role involves PIRs, CAPAs, recalls, audits and cross-functional collaboration in a hybrid work model. The candidate should have 5+ years in Regulatory Affairs/Quality for medical devices, knowledge of US and EU regulations, and strong technical writing skills. #J-18808-Ljbffr Boston Scientific
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...recognize their merit. Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs... ...is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located... ...issues. Develops 510K submissions for medical devices for commercialization in the USA....SeniorMedical deviceTemporary workLocal areaWorldwide- ...whatever your ambitions. Senior Legal CounselAbout the... ...managing legal and regulatory risk. You will also help... ...be opportunities to lead or participate in broader... ..., and Regulatory Affairs.Advise on FDA, FTC and... ...guidance affecting the medical device industry.Participate in...SeniorMedical deviceHourly payFixed term contractWork at officeLocal areaShift work3 days per week
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- ...job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory... ...related field.Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, to include FDA,...SeniorMedical deviceFull timeImmediate start
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...Implantable Systems (AIS) R&D organization is seeking a Senior AI Solutions Lead to join our AI Transformation core team and translate engineering... ...management. Experience in health care, life sciences, medical devices or another highly regulated industry. Experience...SeniorMedical deviceHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory... ...Specialist, UltrasoundThe Senior Regulatory Affairs Specialist... ...of Conformity, and Medical Device Licenses—for various global... ...changes to existing products.Lead global regulatory intelligence...SeniorMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 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
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Senior Manager of Quality and Regulatory Plymouth, MN55441 Posted: 07/09/2026 Employment... ...0,000 + Bonus Industry: Medical Device and Healthcare... ...based execution of clinical affairs processes, as well as... ...assurance compliance. Leading efforts in support of QMS...SeniorMedical devicePermanent employmentContract workLocal areaWorldwideFlexible hours- ...513809Reference25-04468 Job Description: The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions, including... ...successful approval and launch of innovative medical devices. Responsibilities: Prepare, review, and...SeniorMedical device
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...Minnesota City: Maple Grove SummaryThe Lead Engineer, Design Quality supports the quality... ...of products and projects in the medical device, aerospace & defense, industrial, and smart... ...’ technical staff regarding customer/regulatory audits Provide guidance and support to...SeniorMedical deviceTemporary workWork at officeWorldwideShift work- ...passion for cutting‑edge medical technologies, join our... ...day in the life: The Senior Compliance Specialist... ...and patient safety by leading the end‑to‑end... ...and in alignment with regulatory and internal requirements... ...background in medical devices, healthcare or a related...SeniorMedical deviceWork at officeLocal areaFlexible hours
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Cypress HCM is looking for a Senior Design Assurance Engineer in Maple Grove, Minnesota. This role involves ensuring quality input and deliverables for new product development in medical devices. Candidates should have over 5 years of experience in medical device development...SeniorMedical device- Boston Scientific is seeking a Medical Safety professional to apply clinical knowledge across a broad portfolio of devices in the Endoscopy division. You will support safety reporting... ...and MDRs, escalating safety concerns to senior leadership, reviewing promotional...SeniorMedical device
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...individual in this role assists with medical writing and regulatory documentation, including preparation... ...analyze domestic and international medical device regulations to ensure submission... ...detail and accuracy. Pay Rate: $80-120k Seniority level Mid-Senior level Employment...SeniorMedical deviceFull timeWork at office- ...Maple Grove, MN is seeking a Senior Medical Writer to lead CER deliverables and related documentation for regulatory submissions. The role... ...medical writing within medical devices or healthcare, strong writing... ...across R&D, Regulatory Affairs, Quality, and Clinical Teams...SeniorMedical deviceFull time
- ...Principal Product Marketing Manager, IO&E Software - Upstream, to lead software strategy and partnerships for the global IO&E... ...travel. The position requires a Bachelor’s degree and 7+ years in medical devices, with experience in software launches and development roadmaps...SeniorMedical device
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$192k - $275k
ABOUT INSPIRE MEDICAL SYSTEMSInspire is the first of its kind medical device designed to make a difference in the lives of those... ..., act with integrity and lead with respect. With positive persistence... ...! ESSENTIAL JOB FUNCTIONS The Senior Director of Tax will lead Inspire...SeniorMedical devicePermanent employmentWork experience placementLocal areaFlexible hours- Senior Software ManagerTwin Cities, MNAbout the... ...innovative medical technology company... ...Software Manager to lead software development and regulatory compliance efforts... ...and related medical device regulations.Conduct... ...Quality and Regulatory Affairs teams to support global...SeniorMedical deviceFor contractors
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$140k - $185k
...POSITION SUMMARY: The Senior Manager, Manufacturing Operations leads the Manufacturing Operations function... ...a production environment in the medical device or pharmaceutical industry which... ...quality systems, ISO standards, regulatory expectations, audit readiness, deviation...SeniorMedical deviceWork at officeShift work
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