Sage Product Development: Provides product development and manufacturing services for medical device companies.
5+ YOEHigh School diploma; 5+ years in manufacturing/quality environment for medical devices; GD&T; inspection tools; AQL; ability to read engineering drawings.
Lumafield: Accessible industrial CT scanners and cloud-based analysis software
10+ YOEEngineering BS or equivalent, 10+ years experience (consulting/program management or medical device product development), knowledge of medical device processes and regulations (ISO 13485, 21 CFR Part 11), strong communication and executive presentation skills.
Martech Medical Products: Contract manufacturer of medical device components and catheters.
8+ YOE3+ MgmtBachelor's in a technical discipline,8+ years quality experience in medical device or regulated manufacturing,3+ years leading teams,strong knowledge of FDA QMSR (21 CFR Part 820),ISO 13485,capability with CAPA,audits,risk management and continuous improvement.
Stadler Digital Labs: Developing digital software and cybersecurity solutions for rail mobility.
5+ YOE5-10 years in business development, ideally in medical devices or regulated technology; proven complex sales and outbound prospecting; strong stakeholder management; willingness to travel.
Analog DevicesNASDAQ: ADI: Designs and manufactures semiconductors for signal processing and power management.
7+ YOE7+ years cybersecurity/product security experience supporting FDA-regulated medical devices or SaMD, Master's degree (Ph.D preferred), threat modeling, vulnerability management, and familiarity with FDA guidance and cybersecurity frameworks.
ZOLL Medical: Manufactures medical devices and software for emergency care.
5+ YOE5+ MgmtBS in CS/CE required; 5 years as senior/principal engineer and 5 years managing software teams; experience leading software development, project management, and strong leadership; Scrum and medical device experience preferred.
IntertekLondon Stock Exchange: ITRK: Provides global testing, inspection, and certification services for products.
4+ YOEBachelor's in a science/technical field or equivalent, 4+ years medical device industry experience, 2+ years QMS/auditing experience, Lead Auditor training, valid driver's license, willingness to travel extensively (3–5 nights/week).
Gilero: Contract medical device design, development, and manufacturing services.
8+ YOE5+ MgmtBS in Engineering or 4-year technical degree, PMP preferred, 8+ years experience with 5+ years as a project manager in medical devices, knowledge of FDA/ISO, Excel/Word proficiency, must be authorized to work in the US, onsite in Durham 4+ days/week.
International Regulatory Affairs Lead (Medical Devices)
Cupertino, California, United States
OnsiteFull Time
AppleNASDAQ: AAPL: Designs and sells consumer electronics, software, and online services.
Lead a team to support international expansion of regulated medical device features; collaborate across functions; passion for health products and regulatory strategy.
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
4+ YOEBachelors in engineering (or advanced degree) plus relevant experience, systems engineering, user evaluations, software/hardware design, safety risk management, and leadership in medical device development.
FlexNASDAQ: FLEX: Contract electronics manufacturing and supply chain management services.
3+ YOEMinimum 3 years injection molding, mold and tool design experience; interpreting drawings; capacities analysis; proficiency with MS Office/Excel; experience in mold making or medical device manufacturing.
Sunstar Americas: Manufactures oral care products and industrial chemical formulations.
3+ YOE3+ years regulatory/quality experience in US and Canada medical devices; authored a 510(k); Health Canada licensing experience; BS in science or related; strong writing and regulatory system skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, GUDID, UDI, US FDA electronic system
CapgeminiEuronext Paris: CAP: Provides global IT consulting and digital transformation services.
10+ YOEBachelor's degree and 10+ years of software quality assurance experience in regulated environments. Requires medical device, embedded development, design controls, SDLC, risk management, verification, validation, and FDA regulatory expertise.
Software Development Life Cycle (SDLC), IEC 62304, FMEA, CAPA, FDA, ISO, 21 CFR 820, 21 CFR 812, 21 CFR 814
Medical Murray: Development and contract manufacturing of complex medical devices.
3+ YOEBachelor's or master’s in engineering required, 3+ years engineering experience in medical devices, 3+ years project management/project engineering preferred, PMP preferred, experience with FDA/ISO regulated environments, proficiency in Microsoft Office.
Sr. Regulatory Affairs SME - Medical Devices & Diagnostics
Bethesda, Maryland, United States
OnsiteFull Time
Tunnell Government Services: Provides specialized scientific and technical consulting for government agencies.
Regulatory affairs SME for medical devices and IVDs; regulatory strategy, FDA guidance, risk identification, regulatory submissions review, client coordination.
8+ YOE5+ Mgmt8+ years in medical device manufacturing or TIC companies, 5+ years sales/business development, 5+ years P&L/management, Bachelor's required (Masters/MBA preferred), knowledge of FDA 510k/Pre-Approval, CRM and Microsoft/PowerBI proficiency.