438 regulatory manager jobs at 222 companies in Mound, MN
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Regulatory Change Project Manager
Cincinnati or Minneapolis
$86k-$102k/yrHybridFull Time
U.S. BankNew York Stock Exchange: USB: Diversified financial services and banking institution.
5+ YOEBachelor's degree or equivalent experience and typically more than five years of applicable experience. Requires regulatory, financial services, risk, compliance, analytical, facilitation, project management, and communication expertise.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft PowerPoint
Nonin Medical: Privately held medical-device manufacturer making noninvasive monitors, oximeters, capnographs, sensors, and software for clinicians and patients.
7+ YOE3+ MgmtBachelor's degree or equivalent,7+ years regulatory/quality experience in medical device industry,3+ years management,expertise in FDA QSR,ISO 13485,EU MDR,global submissions,510(k)/PMA/SaMD,strong communication.
Wright Engineered Plastics: Private contract manufacturer providing precision plastic injection molding and complex assemblies for medical-device and other regulated OEMs.
15+ YOE7+ MgmtOversee and improve QMS, manage internal audits to ISO 13485 / IATF 16949, drive continuous improvement, lead quality team, 15 years manufacturing experience, 7+ years quality management, 5+ years injection molding experience, valid driver license, travel up to 20%.
Minneapolis or New Hampshire or United States or Canada
$120k-$145k/yrRemoteFull Time
SezzleNASDAQ: SEZL: Financial technology providing buy now, pay later services.
5+ YOE5+ years in bank regulatory reporting with hands-on FFIEC Call Report experience; deep FFIEC and U.S. GAAP knowledge; bachelor's in Accounting/Finance required; CPA/CFA preferred; advanced Excel and regulatory reporting systems experience.
Xcel EnergyNASDAQ: XEL: Major electric and natural gas energy utility provider.
10+ YOEFour-year degree preferred in security management, criminal justice, or business; 10 years industrial security experience; 8 years regulatory project management; driver's license and federal clearance eligibility.
San Francisco or Edina or Los Angeles or Philadelphia or Tampa or Denver or Seattle or New York City or Chicago
$105k-$193k/yrHybridFull Time
Guy Carpenter: Marsh-owned global reinsurance broker and advisory firm serving insurers with analytics and capital solutions.
3+ YOE3+ years insurance regulatory/filing experience (P&C) with California filings, ability to prepare regulator-ready materials, strong project management and communication, bachelor\u0002s or equivalent experience.
Pace Analytical Services: Environmental and life sciences analytical testing services network.
1+ YOEBachelor's in chemistry or related field required, 1-2 years regulatory/compliance experience in the chemical industry, fluent English, proficiency with Microsoft Office/Excel, ability to manage multiple projects and handle repetitive data tasks.
Microsoft Excel, Microsoft Office Products, RMDM, WERCS, HEARS
AtriCureNASDAQ: ATRC: Public U.S. medical-device manufacturer making surgical devices for physicians treating atrial fibrillation, appendage conditions, and postoperative pain.
4+ YOEPrepare and submit global regulatory filings, develop regulatory strategies, support risk management and design control, interact with regulatory agencies; 4+ years device regulatory experience and bachelor’s degree or equivalent.
ResideoNYSE: REZI: Global provider of smart home, security, and building solutions.
10+ YOE10+ years working with product regulations and certifications across safety, home comfort, security, or energy efficiency; experience with agency approval processes, technical documentation and packaging, trademark/copyright considerations, Microsoft Office, and global teams.
Saluda MedicalASX: SLD: Public medical device developing closed-loop spinal cord stimulation therapies for people with chronic pain.
Prepare and manage regulatory submissions, maintain licenses, provide regulatory guidance across product development, and mentor junior staff; tertiary science/engineering qualification and medical device regulatory experience required.
Brooklyn Park or Eagan or Maple Grove or Geneva or United States or Europe
HybridFull Time
Anteris TechnologiesASX: AVR: Public structural heart medical-device developing biomimetic transcatheter aortic valves for patients with aortic stenosis.
Experience in clinical operations, clinical monitoring, physician support, field clinical education, global regulatory compliance, or clinical trial management within the medical device industry.
Back to Nature: Italian family-owned food manufacturer producing pasta, sauces, bakery products, and crispbread for consumers worldwide.
5+ YOEBachelor's in food science/engineering,5+ years QA/food safety experience,certifications (GFSI Lead Auditor,FSMA PCQI,HACCP Manager,Thermal Processing),nut food safety expertise,and ability to lead audits and regulatory programs.
Comfort Medical: Private US direct-to-consumer supplier delivering prescribed catheter, ostomy, and bowel-management supplies to patients nationwide.
5+ YOE2+ Mgmt5+ years in healthcare reimbursement or payer operations, 2+ years leadership, DME experience, knowledge of Medicare/Medicaid/commercial payers, audit and compliance experience, strong communication and project management skills.
Landscape Structures: Employee-owned U.S. manufacturer of commercial playground, water-play, and shade equipment for parks, schools, and communities.
3+ YOEBachelor’s degree or equivalent experience; 3–5+ years in regulatory compliance or materials management; project leadership, technical writing, regulatory analysis, and stakeholder engagement skills required.
MedtronicNYSE: MDT: Global leader in medical technology and healthcare solutions.
7+ YOEBachelor's degree and 7+ years regulatory affairs experience (or advanced degree with 5+ years); experience with FDA 510(k) and CE Mark submissions, labeling and promotional review, and regulatory lifecycle management.
Trelleborg Medical SolutionsNasdaq Stockholm: TREL B: Polymer-based medical device and biopharma contract manufacturer serving healthcare companies worldwide.
15+ YOE15+ years global regulatory/quality leadership in medical devices; engineering degree; ASQ/RAC preferred; ISO 13485/14971; FDA/CE knowledge; able to lead global teams.
eQMS, Quality Management System (QMS), Regulatory Submissions, FDA Regulations, ISO 13485, Regulatory Tools
MedtronicNYSE: MDT: Global leader in medical technology and healthcare solutions.
7+ YOEBachelor's degree and 7+ years regulatory affairs experience (or advanced degree with 5+ years). Experience with FDA submissions (Pre-Sub, 510(k)), CE Mark, regulatory lifecycle, labeling/promotions review, and mentoring staff.
Associate Director/Director for Regulatory Affairs
Minnesota or Minneapolis or New Hope or Michigan or Wyoming or Allegan or Denver or Hendersonville or Waunakee or Lunenburg or Navarre or Foley or Round Lake
RemoteFull Time
Padagis: Generic pharmaceutical manufacturer of prescription and over-the-counter non-oral medicines serving patients and healthcare providers.
7+ YOE2+ MgmtAdvanced life sciences or pharmacy degree; 7–10+ years in pharmaceutical or biotechnology Regulatory Affairs; proven FDA ANDA, IND, and NDA submission leadership; generic drug strategy expertise and strong project management skills.
Biosense Webster: Biosense Webster is a Johnson & Johnson medical-device serving electrophysiologists with cardiac-arrhythmia treatment solutions.
6+ YOEBachelor’s degree in engineering, physical or biological science, or related field; 6+ years in medical devices, including 5+ in regulatory affairs. Expertise in FDA, global regulations, submissions, project management, and negotiations.
Biosense Webster: Biosense Webster is a Johnson & Johnson medical-device serving electrophysiologists with cardiac-arrhythmia treatment solutions.
6+ YOEBachelor’s degree in engineering, physical or biological science, or related field; 6+ years in medical devices, including 5+ years in regulatory affairs. Expertise in FDA, global regulations, submissions, quality, and project management.