Senior Medical Device Regulatory Strategist
Integer Holdings Corporation
Integer Holdings Corporation in Minnesota seeks an experienced regulatory affairs professional to strategically plan, execute and oversee regulatory activities for US and International medical device approvals. You will lead submissions, interact with agencies, and ensure compliance with FDA, EU, ISO and related standards, while coordinating with cross-functional teams to drive product approvals and post-market activities. #J-18808-Ljbffr Integer Holdings Corporation
$80k - $120k
...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...SeniorRegulatoryMedical deviceFull timeWork at office- ...Hiring: Sr. Software Engineer – Medical Device We are seeking an experienced Sr. Software Engineer with a strong background in Embedded... ...through release. Ensure compliance with medical device quality and regulatory standards. Collaborate with cross-functional teams including...SeniorRegulatoryMedical device
- ...Job Opportunities We are seeking a Senior Superintendent for a leading Commercial Construction... ...financial statements and disclosures. Medical Device Representative: collaborate with... ..., ensuring compliance with safety and regulatory standards. Key responsibilities across...SeniorRegulatoryMedical deviceWork experience placement
- ...Senior Quality Assurance Engineer The Senior Quality Assurance Engineer for Beckman... ...Ensure compliance with applicable regulatory agency requirements, published standards... ...field with 5+ years' experience in IVD, Medical Device, or Biotechnology organization preferred...SeniorRegulatoryMedical deviceLocal area
- ...Senior Project Manager – Medical Device Development Minnesota | On-Site | Permanent We are partnering with a medical device CDMO to find a Senior Project... ...Familiarity with 510(k) submission processes and regulatory milestones PMP is not required and will not be weighted...SeniorRegulatoryMedical devicePermanent employment
- .... We're partnering with an innovative medical device company that's redefining how complex cardiac... ...are performed. They're looking for a Senior Software Engineer to join their growing... ...talented Hardware, Systems, Clinical, Regulatory, Quality, and Manufacturing engineers...SeniorRegulatoryMedical device
- ...verification and validation of embedded medical systems, including execution of functional... ..., and documentation aligned with regulatory standards. Ensures product reliability and... ...system‑level testing for embedded medical devices Execute regression, exploratory, and scenario...SeniorRegulatoryMedical device
- ...job is to strategically plan, execute and provide oversight to regulatory activitiesnecessary to obtain and maintain regulatory... ...related field.Minimum Experience: 7+ years of US and International medical device regulatory submission/approvalexperience, to include FDA, MDD...SeniorRegulatoryMedical deviceImmediate start
$130k - $160k
...mission forward. As a global medical technology leader for nearly... ...the quality function a medical device design and manufacturing site... ...corporate objectives and regulatory requirements (QMSR, GMP, ISO,... ...production employees through senior management. Must possess excellent...SeniorRegulatoryMedical deviceHourly payWork experience placementFlexible hours- ...people to join our team! ABOUT THE ROLE Senior Operations Manager We are seeking a... ...operations experience, with at least 5 years in medical device leadership. Preferred Experience Lean... ...data-driven decision-maker with deep regulatory knowledge. Why Join Us Build the...SeniorRegulatoryMedical device
- ...At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency,... ...and respiratory illnesses. The Senior Supplier Quality Engineer is responsible... ...products and materials meet regulatory requirements and internal...SeniorRegulatoryMedical deviceHourly payContract workWork experience placement
$125k - $135k
Job Description Senior Contract Strategist leads end‑to‑end negotiation and drafting of complex, high... ...in sophisticated financial clauses, regulatory commitments, and data/AI‑related provisions... ...equity. Benefits Healthcare (Medical, Dental, Vision) Paid Time Off, Volunteer...SeniorRegulatoryContract workTemporary work$100k - $130k
...compliance-driven development practices within a highly regulated medical device environment. The successful candidate will contribute to the... ...software solutions while ensuring alignment with quality and regulatory requirements. Design, develop, test, and support software...SeniorRegulatoryMedical deviceFlexible hours$93.6k - $131.04k
...At Tactile Medical, we specialise in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. The Senior Quality Engineer provides quality engineering... ...and Supply Chain to ensure regulatory compliance, effective risk...SeniorRegulatoryMedical device$150k - $165k
...Senior Software Engineer St. Louis Park, MN Job Summary: We are seeking... ...software for active implantable medical device systems. This role involves creating robust... ...device development, system integration, and regulatory compliance, with a passion for building...SeniorRegulatoryMedical device- ...Senior Systems Engineer Our Fortune 500 client (One of the world's largest Healthcare... ..., verification, and validation of medical devices. What You'll Be Doing Perform... ...from various sources such as user needs, regulatory standards, human factors, quality, manufacturing...SeniorRegulatoryMedical deviceShift work
$80k - $100k
We are a growing medical device manufacturing company dedicated to improving patient outcomes... ...highest standards of quality, safety, and regulatory compliance, serving healthcare... ...a highly motivated and detail-oriented Senior Accountant to join our growing medical...SeniorRegulatoryMedical deviceLocal area- ...Senior Chemist Location: Plymouth, MN Duration: 12 Months+ Possible... ...remain a global leader in medical technology and solutions.... ...validate safe and effective medical device products that address unmet... ..., FDA and international regulatory requirements, and Good Documentation...SeniorRegulatoryMedical device
- ...the design, development, and management of projects for legacy medical device products. This role focuses on Design Quality activities and... ...Minitab. Strong understanding of Risk Management, C&PA, and regulatory requirements such as FDA QSR, ISO 13485, ISO 14971, ISO 11135...SeniorRegulatoryMedical deviceFlexible hours
$100.27k - $162.29k
...Senior Biostatistician Location: Minneapolis, MN, US... ...to support clinical research, regulatory submissions, and product development... ...with clinical scientists, medical affairs, and regulatory teams... ...experience in medical device, pharmaceutical, biotechnology...SeniorRegulatoryMedical deviceContract workImmediate startFlexible hours$120k - $134k
...Position Summary The Senior Project Manager will lead cross-functional teams within... ..., ensuring products meet customer, regulatory, and business requirements. With visibility... ...product development, particularly in medical devices, and a background in new product...SeniorRegulatoryMedical deviceTemporary workFor contractorsLocal area$127.93k - $176.55k
...6,550.00 Annually POSITION SUMMARY The Senior EHS Manager is responsible for leading... ...but are not limited to the following: Regulatory Compliance & Governance Ensure compliance... ...business continuity plans. Cleanroom & Medical Device Manufacturing Support Ensure safe handling...SeniorRegulatoryMedical deviceLocal area- ...support manufacturing of commercial and non-commercial finished medical devices. Primary responsibility for this role will be supporting... ...testing required per internal procedures, customer alignment and regulatory acceptance requirements provided. Work with purchasing to...SeniorRegulatoryMedical deviceImmediate start
$78k - $156k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...than 160 countries. Job Description Senior Manufacturing Engineer Working at... ...Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S....SeniorRegulatoryMedical deviceFor contractorsWork experience placementWorldwide$80k - $200k
...Veeva is looking for an experienced consultant to lead MedTech Regulatory Information Management (RIM) implementations at Veeva’s... ...Regulatory Operations or Regulatory Affairs specifically within the Medical Device or Diagnostics industry Direct experience with software...SeniorRegulatoryMedical deviceWork at officeLocal areaWork from homeFlexible hours$78k - $156k
...dream of. Employees can qualify for free medical coverage in our Health Investment Plan (... ...the manufacturing process of a medical device and understand and develop process monitoring... ...’s for ethylene oxide cycles per regulatory requirements. Knowledge and ability to perform...SeniorRegulatoryMedical deviceFor contractorsWork experience placementWorldwide- ...A leading global professional services firm is seeking a Senior in Indirect Tax to manage compliance and develop tax strategies. The... ...in sales and use tax. Responsibilities include advising on tax regulatory changes and identifying optimization opportunities. The candidate...SeniorRegulatory
$135.6k - $225.9k
What You Will Do The Senior Manager, Compliance PMO is responsible for leading the project... ...experience Experience working in the medical device, pharma, biotech, or healthcare... ...Compliance, Internal Audit, Risk Management, Regulatory/Quality, or Operations function...SeniorRegulatoryMedical deviceRemote jobTemporary workWork experience placementFlexible hours- ...Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment... ..., Clinical Affairs and Biometrics, the Senior Principal Statistician is responsible... ...Principal Statistician will work closely with regulatory, scientific affairs, health economics,...SeniorRegulatoryMedical deviceTemporary workInterim roleLocal areaWorldwide
- The Senior Quality Engineer is responsible for providing technical quality support to ensure customer, regulatory, and internal requirements are clearly understood and effectively implemented... ...years of experience in a regulated medical device manufacturing environment (ISO/FDA)...SeniorRegulatoryMedical deviceContract workRelocation package
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