Global Regulatory Strategist for Medical Devices
Balt Brasil
Balt Group in Irvine, CA seeks a Senior Principal Regulatory Affairs Specialist to lead global regulatory strategies for sophisticated medical devices. You will prepare submissions, coordinate with teams, and manage regulatory activities across US and international markets. Join a mission-driven organization focused on improving patient lives, with collaboration across functions and rigorous regulatory compliance to support product approvals and lifecycle management. #J-18808-Ljbffr
- ...Kelly Science, Engineering, Technology & Telecom in Irvine, CA seeks an experienced Regulatory Affairs professional to lead global regulatory strategy for medical devices. The role requires crafting regulatory pathways, coordinating 510(k)/PMA submissions in the US and...RegulatoryMedical device
- ...Cordis, LLC in Irvine, CA, seeks a Senior Regulatory Affairs Specialist to lead global submissions (PMA, IDE) and shape regulatory strategy for development and marketed products. You will collaborate with engineering, QA, clinical and other teams to ensure compliance...RegulatoryMedical device
- ...in Irvine, CA is seeking a Senior Principal Regulatory Affairs Specialist to lead regulatory approvals for high-risk medical devices, oversee submissions in the US and... ...guide cross-functional teams. You will develop global regulatory strategies, interact with regulatory...RegulatoryMedical device
- ...Stryker Irvine seeks a Staff International Regulatory Affairs Specialist to drive global product registrations across diverse regulatory pathways. You... ...hybrid role requires 4+ years in regulatory affairs for medical devices or related fields, with experience in international...RegulatoryMedical deviceWorldwide
- ...& Johnson Biosense Webster, Inc. in Irvine, CA, offers an Intern – Medical Devices Regulatory Affairs opportunity to grow your education and career in regulatory affairs. You will assist with global regulatory submissions and help move files into regulatory databases...RegulatoryMedical deviceInternship
- ...Real Staffing is assisting a fast-growing medical device company in Irvine, CA to recruit a Global Logistics Manager who will lead and scale worldwide logistics... ...management. You will partner with Clinical, Regulatory, Quality, Manufacturing, and Finance teams to drive...RegulatoryMedical deviceWorldwide
- ...Embla Medical is seeking a Global Product Marketing Manager to lead cross-functional execution of global... ...coordinating with Product Management, Regulatory, Sales, and MarCom. The role requires 3+ years in life science/medical device product marketing, a Bachelor’s or Master...RegulatoryMedical device
- ...Head of Global Regulatory Strategy About the Company Global biopharmaceutical company developing injectable aesthetics products and... ...for injectable aesthetic products, including biologics, medical devices, and combination products. The role will develop and execute...RegulatoryMedical device
- Edwards Lifesciences is seeking a Regulatory Affairs professional to support process improvements and regulatory initiatives across multiple... ...business units and international teams. You will help monitor global regulatory changes, advise on strategies for expediting...RegulatoryMedical device
- ...Head of Global Regulatory Strategy About the Company Global biopharmaceutical company developing injectable aesthetics products and... ...health authorities, and providing oversight for medical device programs. This role requires a seasoned professional with a...RegulatoryMedical device
- A fast-growing innovative medical device company is seeking a Global Logistics Manager to lead and scale its worldwide logistics operations. This is a... ...while collaborating cross-functionally with Clinical, Regulatory, Quality, Manufacturing, and Supply Chain teams.Key ResponsibilitiesDevelop...RegulatoryMedical deviceWorldwide
$173k - $245k
...heart. Edwards Lifesciences is the leading global structural heart innovation company,... ...strengthen operational excellence and regulatory adherence. Oversight and management of... ...working in Healthcare Compliance in a large Medical Device, Pharmaceutical, and/or Biotech company...RegulatoryMedical deviceFull timeWork experience placementLocal area$200k - $245k
...Kardion Kardion is a cardiovascular medical device company developing next-generation mechanical... .... Position Summary The Director, Global Information Technology defines and... ...as the IT subject matter expert during regulatory inspections, notified body audits, and...RegulatoryMedical deviceCasual workShift work- ...Alcon is seeking a Global Regulatory Affairs Principal Specialist to join the Regulatory Affairs team at Fort Worth, TX, Johns Creek, GA or Lake Forest, CA. You will develop global regulatory strategy for new product development and direct submission work for US, EU and...RegulatoryMedical device
$280k - $315k
...Kardion Kardion is a cardiovascular medical device company developing next-generation mechanical... ...certainty. Summary The Manager, Global Business Systems owns the systems... ...Finance, Supply Chain, Operations, Quality, Regulatory, R&D, HR, and Commercial to understand...RegulatoryMedical deviceWork at officeLocal areaEarly shift- ...Nihon Kohden OrangeMed is seeking a Regulatory Affairs Specialist to coordinate routine regulatory activities for our global medical device business. You will manage registrations, submissions, and post-market requirements across domestic and international markets, collaborating...RegulatoryMedical device
$140k - $180k
...and strategic growth initiatives.Own the global product strategy, roadmap, and... ...through commercialization, coordinating R&D, Regulatory, Clinical Affairs, Operations, Finance,... ...product management experience, preferably in medical devices, dental, orthodontics, healthcare...RegulatoryMedical deviceContract workWork at officeRelocation$99.42k - $127.51k
...About Us Össur is a leading global provider of innovative mobility solutions that help... ...and Regional Downstream Marketing, Regulatory, Sales, Finance, and Customer Service to... ...management and marketing with life science/medical device products. Medical device, orthopedics,...RegulatoryMedical deviceFull timeLocal areaWorldwide- ...Job Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA Summary of Position... ...requirements Ensuring rapid and timely approval of new medical devices and continued approved status of marketed medical devices Serving...RegulatoryMedical deviceVisa sponsorshipRelocation package
- ...: In this critical role, you will lead regulatory strategies, product submissions, and a... ...work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others... ...and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA...RegulatoryMedical deviceWork at office
$260k - $365k
## Global Head of Injectable Aesthetics Regulatory StrategyApplylocations: Orange County: Miamitime type: Full timeposted on: Posted Todayjob requisition... ...products including neurotoxins, fillers and other medical devices.The VP, Global Regulatory Strategy will provide...RegulatoryMedical deviceTemporary workWork experience placementWork at officeLocal areaWorldwide- ...Vice President of Quality Assurance & Regulatory Affairs to lead QA, regulatory compliance... ...in FDA/regulatory affairs for medical devices, leads regulatory submissions (FDA 510(... ...builds a culture of continuous improvement across global operations. #J-18808-Ljbffr...RegulatoryMedical device
$74k - $104k
...Edwards Lifesciences seeks a Labeling Specialist to manage labeling activities and regulatory change requests for cardiovascular medical devices across global markets. The role involves coordinating cross-functional labeling solutions, overseeing document development,...RegulatoryMedical deviceWork at office$102.7k - $171.1k
...Compliance Engineer Irvine, CAJoin Stryker in a key role supporting global regulatory compliance across the product lifecycle. This position... ...for standards and regulations management, ensuring medical device products and quality systems remain aligned with evolving global...RegulatoryMedical deviceFull timeFor contractors- ...SprintRay, a Huntington Beach, CA-based company, seeks a Regulatory Labeling and Documentation Specialist to ensure medical devices meet US, EU, and MDSAP requirements. You will manage labels, IFUs, UDI data, and related QMS documentation in a fast-growing environment...RegulatoryMedical device
$110.1k - $183.4k
...Flexibility: Hybrid or OnsiteStaff International Regulatory Affairs SpecialistIrvine, CAIn this... ...Affairs role, you will ensure global product registrations move efficiently... ...regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or related...RegulatoryMedical deviceFull timeFor contractorsLocal area- ...Kardion, a cardiovascular medical device company, seeks a Director of Global Information Technology to unify and lead the IT organization across Irvine and Stuttgart, guiding architecture and strategic investments. You will build a global operating model, ensure FDA/ISO...Medical device
$200k - $220k
...Kardion Kardion is a cardiovascular medical device company developing next-generation... ...cross-functionally with R&D, Quality, Regulatory, Clinical, and Supply Chain to ensure robust... ...inspections, CAPA, change control, and global commercialization activities....RegulatoryMedical deviceContract workWork at officeFlexible hours- ...Who Are We? ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance... ...solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic...RegulatoryMedical device
- ...We are searching for a Director of Regulatory Affairs with deep expertise in invasive electromechanical medical devices and extensive experience preparing and submitting 51... ...Clinical, and Operations to ensure compliance with global regulations, support product development,...RegulatoryMedical device
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