Nonin Medical: Designs and manufactures noninvasive medical monitoring equipment.
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.
Arrow Finishing: Provides precision surface finishing and chemical processing for metal components.
5+ YOEBachelor's degree required, 5+ years regulatory/compliance experience in regulated or manufacturing environments; proficiency with Microsoft Office 365 and compliance documentation; strong analytical and communication skills.
Xcel EnergyNASDAQ: XEL: Provides electricity and natural gas services to multi-state customers.
5+ YOEManage regulatory case filings, prepare testimony, coordinate interdisciplinary teams; BA/BS in business or related, 5+ years regulatory experience preferred, Excel/Word proficiency, periodic overnight travel.
Minneapolis or Jacksonville or Fort Worth or Memphis or Lafayette
$154k-$232k/yrHybridFull Time
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
7+ YOE5+ MgmtBachelor's degree, 7+ years product release/regulatory operations experience (5+ with advanced degree), 5+ years managerial experience, strong knowledge of global regulatory requirements (FDA, EU MDR), leadership and process improvement experience.
Microsoft Office, Microsoft SharePoint, GTS, SAP, GUDID, EUDAMED, RIM
Minneapolis or Jacksonville or Fort Worth or Memphis or Lafayette or United States
$154k-$232k/yrHybridFull Time
MedtronicNYSE: MDT: Developing and manufacturing medical technologies and therapies globally.
7+ YOE5+ MgmtBachelor's degree, 7+ years supporting or leading product release/distribution/regulatory operations (5+ with advanced degree), 5+ years managerial experience, strong knowledge of FDA/EU MDR/international regulatory requirements, ability to lead teams.
Microsoft Office, SharePoint, GTS, SAP, UDI, GUDID, EUDAMED, RIM
Seaway Plastics Engineering: Produces custom plastic injection molded parts and complex assemblies.
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%.
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
Marsh McLennanNYSE: MRSH: Provides global insurance brokerage, risk management, and professional consulting services.
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: Provides analytical testing and scientific laboratory services.
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: Manufacturer of medical technologies for atrial fibrillation treatment.
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: Manufacturing and distributing home comfort and security 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.
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.
Experience in clinical operations, clinical monitoring, physician support, field clinical education, global regulatory compliance, or clinical trial management within the medical device industry.
Barilla: Manufacturing and global distribution of pasta and bakery products.
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.
Bio-TechneNASDAQ: TECH: Provides reagents, instruments, and diagnostic tools for life sciences.
3+ YOEBachelor’s in life sciences (Master’s acceptable), 3+ years regulatory affairs experience in biotech (or Master’s with up to 3 years), knowledge of FDA/IVDR/ISO standards, experience preparing regulatory submissions, and strong project management and communication skills.
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
4+ YOEBachelor's or equivalent experience, minimum 4 years in a regulated industry (2-5 years regulatory preferred), strong verbal/written communication, domestic and international regulatory knowledge, ability to lead submission activities.
ColoplastNasdaq Copenhagen: COLO B: Manufacturer of medical devices for intimate healthcare conditions
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.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
4+ YOEBachelor's degree or equivalent and minimum 4 years in a regulated industry; 2-5 years regulatory experience preferred. Must prepare regulatory submissions, develop multi-country strategy, support pre/post-approval activities, and communicate with authorities.
TrelleborgNasdaq Stockholm: TREL B: Develops engineered polymer solutions to seal, damp, and protect.
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