Lead Regulatory Affairs Specialist, Medical Devices
Boston Scientific
Boston Scientific is hiring a Principal Regulatory Affairs Specialist in Maple Grove, MN, to lead regulatory strategy for a broad ablation portfolio. The role involves coordinating IDEs, 510(k)s, and EU MDR submissions, collaborating across R&D, Quality, Operations and Clinical teams, and engaging with FDA and EU notified bodies to secure timely regulatory clearances. The ideal candidate has 7+ years in Regulatory Affairs, strong technical writing, and a proven track record of global submissions #J-18808-Ljbffr Boston Scientific
$88k - $130k
...Position Summary This is a mid‑level Regulatory Affairs position responsible for integrating regulatory knowledge throughout the product... ...and manufacturing changes to commercially distributed medical devices Conduct appropriate research to develop strong regulatory...Medical deviceTemporary workWork at officeFlexible hours$102.1k - $194k
...week. Responsibilities Represent the Regulatory Affairs function on cross‑functional teams for... ...and prepare submissions for Class II medical devices. Create innovative regulatory pathways... ...timely, compliant updates to filings. Lead interactions with the U.S. FDA and EU...Medical deviceWork at officeLocal areaOverseas3 days per week- ...experience every day.The Principal Regulatory Affairs Specialist is responsible for planning, managing... ...and prepare submissions for Class II medical devices.Create innovative regulatory... ...timely, compliant updates to filings.Lead interactions with the U.S. FDA and EU...Medical deviceHourly payWork at officeLocal areaWorldwideShift work3 days per week
$102.1k
...Principal Regulatory Affairs Specialist - Advertising & Promotion (Ad Promo) Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location... ..., promotional, sales support and training materials for medical devices used in interventional cardiology. The role applies a...Medical deviceHourly payWork at officeLocal areaShift work3 days per week- Teleflex is seeking a mid-level Regulatory Affairs professional to manage regulatory processes throughout the product lifecycle. This role... ...The ideal candidate will have 2-5 years of experience in medical devices, strong analytical skills, and proficiency in Microsoft...Medical deviceWork at office
- ...technologies. The company seeks professionals for Clinical & Regulatory Affairs roles to support clinical research and regulatory... ...development opportunities. Candidates with experience in Class III medical devices are especially encouraged to apply. #J-18808-Ljbffr...Medical device
$88k - $130k
...Regulatory Affairs Specialist Date: Jun 26, 2026 Location: Maple Grove, MN, US Company: Teleflex... ...As a global provider of medical technologies, Teleflex is driven by our... ...to commercially distributed medical devices • Conduct appropriate research to develop...Medical deviceTemporary workWork at officeFlexible hours- Boston Scientific Gruppe is seeking a Regulatory Affairs professional to join their Interventional Oncology and Embolization team in Maple... ...strategies and managing submissions for Class II medical devices, ensuring compliance with both US and EU regulations. The...Medical device
$120k - $140k
...company’s notified body and regulatory agency registration processes... ...AND RESPONSIBILITIES Lead quality initiatives related... ...team, including engineers, specialists, and technicians Establish... ...associated to Class II and III medical device design, manufacturing, servicing...Medical deviceTemporary workLocal area$110.18k - $120k
...Regulatory Affairs Specialist Company: Heraeus Location: Fridley, MN Position Summary The Regulatory Affairs... ...They review post‑market changes for devices currently marketed to determine... ...educate cross functional peers on new medical device regulations, such as EU MDR or...Medical deviceFull timeRemote work$65.8k - $125k
...Product Analyst III based in Maple Grove, Minnesota. In this role, you will analyze customer feedback and manage regulatory submissions for medical devices. The position requires a Bachelor’s degree and at least 3 years of experience in medical device complaint handling...Medical device$18 - $24.5 per hour
...Companies, Inc. in Brooklyn Park is seeking a Production Operator Assembler to perform machine operations, assembly, and inspection of medical device components. This position offers a pay range of $18.00 - $24.50 per hour, depending on experience. Ideal candidates will have...Medical deviceHourly pay$132.9k - $199.4k
...division. This role is based in Maple Grove, MN, and involves leading the global strategy for vascular closure and catheters,... ...marketing skills, and at least 5 years of relevant experience in the medical device space. The pay range for this role is between $132,900 - $199...Medical device- ...of the Supply Chain team, the Category Specialist drives competitive advantage through effective... .... About the Role: ~ Lead the development and execution of comprehensive... ...tools. ~ Understanding of medical devices and industry regulations. ~ Willingness...Medical deviceContract workFlexible hours
$30.06k
...programs Experience training others Preferred qualifications: 1 year of work experience in manufacturing is preferred Previous medical device experience preferred, but not required. This position requires proficiency in communication and understanding of English, including...Medical deviceHourly payWork experience placementWork at officeLocal areaRelocationRelocation packageAll shiftsMonday to FridayMonday to ThursdayFlexible hoursShift workNight shiftDay shiftAfternoon shift- B Capital in Maple Grove, Minnesota, is seeking a Principal Regulatory Affairs Specialist to join their Interventional Oncology and Embolization team. This role is responsible for planning and managing regulatory submissions to FDA and EU, supporting new product development...Medical deviceWork at office3 days per week
- ...compliance activities related to complaint handling and ensuring adherence to regulatory requirements. Qualified candidates will have a Bachelor’s degree and at least 7 years in the medical device industry. A strong background in leadership and project management is...Medical deviceWork at office
- A global technology group is looking for a Project Manager to lead the development of cost models, track project performance, and... ...Engineering or related field, with over 3 years of experience in the Medical Device industry and 2 years in a leadership role. Applicants should...Medical deviceFull time
- Anteris Technologies in Maple Grove is looking for a QC Inspector responsible for performing inspections in a regulated medical device manufacturing environment. The ideal candidate will perform receiving inspections, biological tissue inspections, and maintaining thorough...Medical deviceDay shift
$102.1k
...reflecting the culture our employees experience every day. This Regulatory Affairs Principal role supports the review and approval of... ..., promotional, sales support and training materials for medical devices used in interventional cardiology. The role applies a risk...Medical deviceHourly payWork at officeLocal areaShift work3 days per week$23.08 - $33.89 per hour
...Overview About Cretex Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device...Medical deviceHourly payContract workTemporary workWork at officeLocal areaMonday to FridayShift workDay shift$19.15 - $38.35 per hour
...dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP... ...experienced Operations/Production Group Lead. This position ensures the effective use... ...leading a small team to assemble medical devices in accordance with approved manufacturing...Medical deviceWork experience placementWork at officeShift workAfternoon shift- Nextern, Inc. in Maple Grove, Minnesota, is seeking a qualified Quality Assurance Specialist to ensure production and process control compliance in medical device manufacturing. Responsibilities include monitoring production staff, performing Device History Record reviews...Medical device
$23.08 - $33.46 per hour
...Overview Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in injection... ...to uphold product quality and regulatory requirements. The successful candidate...Medical deviceHourly payContract workTemporary workLocal area$55k - $75k
...HCM is looking for a detail-oriented Quality Inspector to ensure precision-manufactured components meet quality standards in the medical device sector. In this role, you will carry out both in-process and final inspections using calibrated equipment and maintain...Medical device- ...(VIP) to improve or revise existing processes for cost savings. Provide technical support or direction to operators and medical device specialists. Support shutdowns, which may include staying late to ensure equipment is safely de‑energized. Required Qualifications Minimum...Medical deviceRelocationShift workWeekend workDay shift
- ...Projects (VIP) to improve/revise existing processes for cost savings Provide technical support or direction to operators and medical device specialists with assistance Support shutdowns (which may include staying late to make sure equipment is safely de-energized) Required...Medical deviceShift workWeekend workDay shift
- Boston Scientific Gruppe in Maple Grove, Minnesota, is seeking a dedicated professional for a medical device role focusing on troubleshooting and continuous improvement projects. The position requires working closely with vendors and engineers to ensure production goals...Medical deviceWork at officeNight shift
$100.9k - $151.3k
...About Cretex Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in... ...based quality control strategies, regulatory compliance, and continuous improvement...Medical deviceContract workShift work- Advantage Technical is seeking a Quality Technician in Maple Grove, MN, for a medical device manufacturer. This role involves executing V&V test protocols, maintaining testing equipment, and supporting projects in a regulated environment. The ideal candidate has experience...Medical deviceWeekly payContract work
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