Global Medical Device Regulatory Strategist
Integer Holdings Corporation
Integer Holdings Corporation in Plymouth, MN seeks a regulatory affairs leader to plan, execute, and oversee regulatory activities for US and international markets. The role ensures compliance with FDA, ISO, and other standards, supporting product submissions, testing strategies, and post-market activities. The candidate will guide product teams, manage submissions, and work with agencies to obtain approvals. Requires 7+ years’ medical device regulatory experience and strong communication skills. #J-18808-Ljbffr Integer Holdings Corporation
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global Medical Device Regulatory Strategist in Minneapolis, MN vacancy
$135k - $145k
...- innovating at the speed of life.As a global leader in clinical diagnostics, Beckman... ...partnering constructively with Quality, Regulatory, and Operations stakeholders.The... ...and technology transfer projects in the Medical Device or Diagnostics regulatory environment,...RegulatoryMedical deviceFull time$91.7k - $130k
Job Description:The Global Brand & Campaign Strategy Manager is responsible for defining... ...-facing communications meet brand, regulatory, and quality expectations.Risk Management... ....Experience in healthcare, dental, or medical device industries preferred.Demonstrated ability...RegulatoryMedical deviceFull timeContract work$200k - $220k
The Director, Global PMO for Beckman Coulter Diagnostics is responsible for driving and... ....Significant experience in diagnostic/medical device regulated environment (manufacturing, R... ...in the Medical Device or Diagnostics regulatory environmentExcellent leadership, communication...RegulatoryMedical deviceHourly payFull timeRemote workWork from homeFlexible hours$142.21k - $213.32k
...role is responsible for leading the global upstream marketing team tasked... ...closely with R&D, Clinical Affairs, Regulatory Affairs, Quality Assurance, Medical Affairs, Operations, and other functional... ...commercial roles within medical devices or healthcare.Experience...RegulatoryMedical deviceImmediate startWorldwideFlexible hours$165.55k - $260.15k
...essential in everyday technology devices from smartphones to electric... ...processes across Spectrum’s global Healthcare manufacturing... ...meet critical-to-quality (CTQ), regulatory, and customer requirements.Operational... ...experience, ideally in the medical device manufacturing industry...RegulatoryMedical deviceFlexible hours$113.3k - $226.7k
Senior Product Manager, Global Upstream Marketing - TAVI Abbott is a global healthcare... ...and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...across R&D, Clinical, Medical Affairs, Regulatory, Health Economics, Operations, and regional...RegulatoryMedical device- AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate and... ...will submit 510(k), PMA supplements, and global filings, while guiding regulatory... ...role requires regulatory expertise for medical devices, strong technical writing, and ability...RegulatoryMedical device
- ...Medtronic Global Regulatory Affairs Team Member Careers that change lives start here. Medtronic... ...patients first developing innovative medical technologies that improve the lives of... ...advancing Global Harmonization for medical device regulations. You will monitor,...RegulatoryMedical deviceH1bWork at officeLocal areaImmediate startFlexible hoursShift work
- Laborie Medical Technologies is seeking a Regulatory Affairs Specialist for a hybrid role in Minnetonka, MN. You will support global product registrations and lifecycle maintenance for the US,... ...engineering and 1-3 years’ medical device regulatory experience are required...RegulatoryMedical device
- ...'s Electrophysiology business in Plymouth, Minnesota, seeks a regulatory affairs specialist to prepare documentation for regulatory submissions... ...comprehensive career development and competitive benefits, including medical coverage and retirement plans. #J-18808-Ljbffr AbbottRegulatoryMedical device
- ...MarlboroughDiversity - Innovation - Caring - Global Collaboration - Winning... ...to serve as a Global Medical Director within the... ...Development (R&D), Quality, Regulatory Affairs and Commercial teams... ...including safety signal evaluation, device performance assessment and health...RegulatoryMedical deviceHourly payRelocationShift work
$249.5k - $374.3k
...As VP Quality, Global Life Sciences you will be accountable for the enterprise quality... ...product quality, patient safety, regulatory compliance, inspection readiness, and reliable... ...in the pharmaceutical, biotechnology, medical device, or broader Life Sciences industry in...RegulatoryMedical deviceHourly payMinimum wageFull timeLocal area- ...GroveDiversity - Innovation - Caring - Global Collaboration - Winning... ...development of innovative medical technologies.As a senior... ...ensure compliance with global regulatory requirements. This position offers... ...:Experience in the medical device industry.Experience supporting...RegulatoryMedical deviceHourly payFull timeWork at officeLocal areaShift work
- Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within... ...possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and...RegulatoryMedical device
- A medical device company is seeking a Clinical Research Associate to manage and monitor global clinical studies ensuring compliance with regulatory requirements. This remote position aims to support study site management and assists in the development of clinical study...RegulatoryMedical deviceRemote work
HistoSonics, Inc.
Minneapolis, MN5 days ago - ...: Inspect, test, and evaluate returned medical devices as part of the complaint handling process. Register returned products in the global complaint handling database. Manage inventory... ...processes. Maintain compliance with quality systems and regulatory requirements....RegulatoryMedical device
Three Point Solutions
Minneapolis, MN5 days ago $325k - $430k
As a global medtech company, we are driven by our Vision of changing... ...Marketing, Market Access, Medical Affairs, and Product Development... ...adheres to all quality and regulatory expectations.Skills and... ...experience within the Medical Devices / Neurostimulation industry.•...RegulatoryMedical deviceFull timeRemote workWorldwide- Abbott is seeking a Regulatory Affairs Specialist II to work on-site in Plymouth, MN. This role requires strong... ...skills while preparing and supporting global regulatory activities for implantable medical devices. With 2-3 years of experience in a regulated industry...RegulatoryMedical device
- AtriCure, Inc. seeks a Senior Regulatory Affairs Specialist to originate and maintain marketing privileges across US and international markets. This role will prepare submissions and support regulatory strategies for new product development and post-market changes. You...RegulatoryMedical device
- ...the Company Growing cardiovascular medical device company focused on commercial products... ...quality, supplier quality, compliance, and global quality initiatives. This executive... ...record in supporting clinical studies and regulatory inspections. Applicants for the VP of...RegulatoryMedical device
Confidential
Minneapolis, MN5 days ago $30 - $38 per hour
...Plymouth, MN. This role focuses on regulated medical device manufacturing and involves close... ...with required validation requirements and regulatory standards. Develop tooling and... ...26. About Actalent Actalent is a global leader in engineering and sciences services...RegulatoryMedical deviceContract workTemporary workMonday to FridayDay shiftActalent
Minneapolis, MN7 days ago$169.22k - $253k
...73 Position Summary The Director, Global Product Quality – Manufacturing Product... ...controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP... ..., or related field • Experience with medical devices/combination products At least 8 years...RegulatoryMedical deviceFull timeContract workTemporary workLocal areaRemote workWorldwideFlexible hoursOtsuka America Pharmaceutical Inc.
Saint Paul, MN2 days ago- ...Biocompatibility), to advance a portfolio covering drugs, medical devices, and drug-device combinations. You will apply... ...safety strategies, perform risk assessments, and support regulatory submissions within a global team. The role reports to the Associate Director,...RegulatoryMedical device
- ...part of a team working to improve lives globally through medical technology innovation. The Design... .... Ensures compliance to customer and regulatory requirements and assists with the successful... ...for novel and existing medical devices, including risk management plans and...RegulatoryMedical deviceWork experience placement
- AtriCure, Inc. seeks a Senior Regulatory Affairs Specialist to prepare and submit regulatory documents (510(k), PMA, EU/Canada/Japan)... ...other agencies. Requirements: Bachelor’s degree, 4+ years in medical device regulatory affairs, strong writing and communication skills;...RegulatoryMedical deviceWorldwide
- ...and technical support within a regulated medical device manufacturing environment, with a... ...Operations, Engineering, Manufacturing, and Regulatory teams to ensure products and processes... ..., MDD/MDR, and applicable customer and global regulatory requirements. Serve as a quality...RegulatoryMedical device
Brio Group
Minneapolis, MN1 day ago - ...the OpportunityAn innovative medical technology company is seeking... ...lead software development and regulatory compliance efforts for the... ...IEC 62304 and related medical device regulations.Conduct software... ...Regulatory Affairs teams to support global regulatory submissions.Risk...RegulatoryMedical deviceFor contractors
- ...highly motivated Sr. Quality Engineer to support global quality improvement initiatives across the company's medical device product portfolios. This role will serve as a... ..., cost reduction, operational efficiency, and regulatory compliance.The ideal candidate will bring...RegulatoryMedical device
Minnesota Jobs
Minneapolis, MN1 day ago $160k
...career to the next level by joining a global medical device market leader in diabetes care? At... ...driving sales excellence.A business strategist with the ability to develop and execute... ...StrategyStay informed about current trends, regulatory changes, and competitive products,...RegulatoryMedical deviceFull timeRemote workNight shift$70k - $100k
...Quality System by overseeing Device History Record (DHR) review activities... ...compliance with applicable medical device regulations while... ...internal stakeholders and regulatory audits. Responsibilities... ...About Actalent Actalent is a global leader in engineering and sciences...RegulatoryMedical devicePermanent employmentWork at officeMonday to FridayActalent
Minneapolis, MN3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Medical Device Regulatory Strategist. Be the first to apply!
Related searches
- account strategist Minneapolis, MN
- senior brand strategist Minneapolis, MN
- strategist Minneapolis, MN
- strategy consultant Minneapolis, MN
- investment strategist Minneapolis, MN
- media strategist Minneapolis, MN
- communications strategist Minneapolis, MN
- design strategist Minneapolis, MN
- business strategist Minneapolis, MN
- technology strategist Minneapolis, MN