Senior Regulatory Affairs Lead — Medical Devices
AtriCure, Inc.
AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate documents to obtain and maintain marketing privileges worldwide. You will prepare submissions, including US 510(k) and PMA supplements, and handle EU, Canada, Australia, and other international filings. The role serves as regulatory lead on development projects, supports post-market changes, and collaborates with FDA, EU Notified Body, Health Canada and others to facilitate timely reviews. #J-18808-Ljbffr AtriCure, Inc.
- ...requirements. The role combines on-site leadership at our Chaska, MN headquarters with remote work flexibility, reporting to the VP of Operations, QARA, and Customer Service. A strong background in medical device quality is essential. #J-18808-Ljbffr IMRIS Imaging, Inc DBA IMRISSeniorMedical deviceRemote work
$106k - $130k
...AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib... ...professionally and personally. POSITION SUMMARY: The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and...SeniorMedical deviceTemporary workWork experience placementWork at officeLocal areaWorldwide- TechDigital Group is seeking a regulatory affairs professional in the United States to lead pre‑market and post‑market submissions for IVD medical devices. The role requires expertise in registration and commercialization, with proven 510(k) author experience and RAC certification...Medical device
$230k - $250k
...everything possible. The Senior Director, Quality... ...site execution, ensures regulatory compliance, and drives... ...Chain, and Regulatory Affairs.This position reports... ...cross‑functional partners.Lead and be accountable for... ...‑vitro diagnostics or medical device industry, with direct...SeniorMedical deviceFull timeLocal area- ...AtriCure seeks a Senior Regulatory Affairs Specialist to prepare and submit regulatory submissions for medical devices across US and international markets. The role involves developing regulatory strategies, managing 510(k) and PMA applications, and supporting new product...SeniorMedical device
- ...Clinical Risk Evaluation (CRE) Senior Scientist/Program... ...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and... ...product performance, medical affairs, Clinical R&D, Quality Engineering, regulatory affairs, product...SeniorMedical deviceWork experience placement
$150k - $175k
...in people's lives. Our medical devices, software and related... ...position is responsible for leading a growing team to... ...with legal and regulatory standards and company... ...overseeing key Clinical Affairs functions and supporting... ...provide regular updates to senior leadership.Manage...SeniorMedical deviceMinimum wageOngoing contractFull timeContract workTemporary workWork at officeLocal areaRemote workWorldwideNight shift3 days per week- ...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
- ...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
$110k - $140k
I'm working with a rapidly growing medical device company developing groundbreaking therapeutic... ...technology and they're looking to add a Senior Supplier Quality Engineer to their team.... ...device platform.What you'll be doing: * Lead supplier audits, qualifications, and performance...SeniorMedical device- ...matrixed environment.Be able to lead project teams on a variety of... ...to the client and Freudenberg Medical.Identify and recommend... ...and experience in the medical device field.6 - 10 years’ experience... ...frequently (oral and written) both to senior management, customers and...SeniorMedical deviceFull timeContract workFor contractors
$117.75k - $172.7k
...primary purpose of this position is to lead technical discussions, manage new business... ...and operating procedures, and other regulatory requirements. New Opportunity Identification... ...to component or assembly in the medical device industry. Prefer to have experience selling...SeniorMedical deviceFull timeImmediate start- ...Senior Principal Statistician AtriCure, Inc. provides innovative... ...System is the first medical device to receive FDA approval for... ...the Vice President, Clinical Affairs and Biometrics, the Senior Principal... ...will work closely with regulatory, scientific affairs, health...SeniorMedical deviceTemporary workInterim roleWorldwide
$115.5k - $169.4k
...ITGR) is one of the largest medical device contract development and manufacturing... ...customers through industry-leading engineering and... ...operating procedures, and other regulatory requirements. You will develop... ...failure is not an option. Senior Process Development Engineer...SeniorMedical deviceFull timeContract workImmediate start- ...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
- ...from various sources such as user needs, regulatory standards, human factors, quality,... ...challenges and risk scenarios and prepare, lead, and execute mitigation strategies to... ...science discipline Prior experience in medical devices, preferably for intensive care unit (ICU...SeniorMedical deviceRemote workShift work
$107k - $142k
Job TitleR&D Senior Engineer, Human Factors (Plymouth, MN)Job DescriptionR&D Engineer,... ...commercialization to treat vascular disease, while leading detailed design, testing, prototyping,... ...working in product development in the medical device industryKnowledge of catheter design/...SeniorMedical deviceFull timeWork experience placementWork at officeImmediate startWork visaRelocation package3 days per week- ...236794Reference26-02012 Summary: As a Senior Systems Verification and Validation Engineer... ...testing effort while maintaining regulatory and quality compliance. Use Data and Statistics... ...-controlled systems, particularly medical devices developed under the rigor of a quality...SeniorMedical deviceContract workImmediate start
$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$60k - $70k
...key member of the Quality team, the Senior Lab Technician will be responsible... ...testing of receiving inspection lots, devices and materials for regulatory submissions, and for management of... ...degree ~3-5 years of experience in medical devices and manufacturing ~...SeniorMedical device$99.88k - $129.25k
...product introductions, and ensure regulatory compliance. This is an... ...time. What You'll do as a Senior Process Manufacturing... ...and production constraints. Lead root cause analysis and implementation... ...Prefer experience within the medical device manufacturing industry, or...SeniorMedical deviceFor contractorsWork at officeLocal area$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$106k - $170k
ABOUT INSPIRE MEDICAL SYSTEMSInspire is the first of its kind medical device designed to make a difference in... ...act with integrity and lead with respect. With positive... ...! POSITION SUMMARYThe Senior Human Resources... ...procedures, policies, and regulatory requirements.Support continuous...SeniorMedical deviceWork experience placementLocal areaFlexible hours$78k - $156k
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...OpportunityWe are recruiting for a Senior R&D Engineer, Electrophysiology... ...external resources (clinical, regulatory, customers, etc.) to ensure development...SeniorMedical deviceWorldwideShift work$113.3k - $226.7k
...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and... ...than 160 countries. Senior Global Marketing... ...with Clinical and Med Affairs teams to drive our podium... ...development Partner with regulatory colleagues in the...SeniorMedical deviceLocal areaWorldwide$78k - $156k
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...EP division in R&D. As the Senior Preclinical Interventionalist,... ...concept feasibility and formal regulatory submission. Plan, coordinate...SeniorMedical deviceFor contractorsWorldwide$78k - $156k
...Senior Development Quality Engineer supporting Abbott's Electrophysiology... ..., Minnesota. This role leads design verification and... ...complex disposable catheter medical devices, manages multidisciplinary teams... ...phases, and ensures regulatory compliance with FDA and ISO...SeniorMedical device- ...ambitions. About the role:Lead the planning, execution and... ...Sales Training, HEMA, R&D, Medical Education/Medical Affairs, Legal/Compliance, Finance,... ...operations, healthcare, medical device or another regulated... ...with multiple workstreams, senior leadership stakeholders and...SeniorMedical deviceHourly payWork at officeLocal areaRelocation packageShift work
- Job-ID32834640Reference26-01421Summary: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 manufacturing.Strong...SeniorMedical deviceContract work
$95k - $118k
Position Summary The Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance... ...Preferred: Experience with medical device or other regulated industries. ASQ, QMSR or...SeniorMedical deviceTemporary workFor contractorsWork at officeLocal area
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