Global Medical Device Regulatory Affairs Specialist
NIHON KOHDEN OrangeMed
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 with internal teams, sales offices, distributors, and regulatory partners. Ideal candidates have a Bachelor’s degree in a technical field, at least 3 years in Regulatory Affairs for medical devices, and strong writing, #J-18808-Ljbffr
- ...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...Medical deviceWorldwide
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- 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 approvals...Medical device
$80k - $95k
The Regulatory Affairs Specialist is responsible for coordinating and executing routine regulatory activities... ...support the company’s worldwide medical device business. This position supports... ...appropriate. Duties and Responsibilities Global Product Registrations and Regulatory...Medical deviceWork at officeWorldwideWeekend workAfternoon shift$110.1k - $183.4k
...: Hybrid or OnsiteStaff International Regulatory Affairs SpecialistIrvine, CAIn this International... ...Affairs role, you will ensure global product registrations move efficiently... ...regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or related...Medical deviceFull timeFor contractorsLocal area$92k - $138k
...here. Medtronic is a global leader in healthcare... ...developing innovative medical technologies that improve... ...conditions. The Regulatory Affairs organization partners... ...Senior Regulatory Affairs Specialist serves as a... ...initiatives.Coordinate Unique Device Identification (UDI)...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$80k - $100k
...Regulatory Affairs SpecialistBring more to life.Are you ready to accelerate... ...speed of life.Masimo is a global medical technology company that... ...possible.The Regulatory Affairs Specialist is responsible for... ...regulatory assessments of medical device regulations to help effective...Medical deviceWork experience placementWorldwide$170k - $200k
...and institutions to develop elegant medical devices. Our products are being used by physicians... ...devices for stroke. As the premier global neurovascular platform always... ...this opportunity – Senior Principal Regulatory Affairs Specialist The Sr. Principal Regulatory Affairs...Medical device$74k - $104k
...Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory AffairsInnovation... ...is the leading global structural heart innovation... ...international affiliatesSupport FDA device listings, establishment... ...Regulations relevant to medical devices, medium risk (i.e....Medical deviceWork experience placementWork at officeWorldwide$120k - $155k
...Lead regulatory strategy and submission activities for Qnovia's drug-device combination products across FDA, MHRA, and other global regulatory bodies. About the Role... ...Kingdom. As a Regulatory Affairs Specialist, you will develop... ...pharmaceutical or medical device industry...Medical deviceLocal areaFlexible hours- ...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...Medical device
- Ensure compliance with global regulations and regulating agencies... .... Develop and implement regulatory strategies and processes to... ...assessments for class II and III medical devices. Develop Technical... ...of experience in Regulatory Affairs or other related discipline...Medical deviceLocal areaWorldwide
- ...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...Medical 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...Medical device
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- ...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
- ...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...Medical device
- ...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...Medical device
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$260k - $365k
## Global Head of Injectable Aesthetics Regulatory StrategyApplylocations: Orange County: Miamitime type: Full timeposted... ...of the Global Regulatory Affairs Injectable Aesthetics team including... ...neurotoxins, fillers and other medical devices.The VP, Global Regulatory Strategy...Medical deviceTemporary workWork experience placementWork at officeLocal areaWorldwide- ...JenaValve Technology in Irvine, CA invites a Manager, Global Transportation & Logistics to lead warehouse operations, transportation planning, and high‑value inventory management critical to our commercial and clinical operations. You will oversee transit data, network...Medical device
- ...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...Medical deviceWorldwide
- Job-ID31853494Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic... ...product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of...Medical device
- ...This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems...Medical deviceWork at office
- ...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...Medical device
- ...& 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...Medical deviceInternship
$55 - $60 per hour
Take your regulatory affairs expertise to the next level with an opportunity... ...diagnostic products on a global scale. This role offers the... ...Matters As a Regulatory Affairs Specialist III, you will help ensure... ...degree in Biology, Chemistry, Medical Technology, or a related scientific...Hourly payTemporary workMonday to Friday- ...Masimo Corporation in Irvine, CA is seeking a Regulatory Affairs Specialist to obtain domestic and internal regulatory clearances for medical devices, ensuring compliance with FDA and ISO 13485 standards. This on-site role reports to the Director, Regulatory Affairs and...Medical device
- ...fast-growing innovative medical device company is seeking a Global Logistics Manager to lead... ...with Clinical, Regulatory, Quality, Manufacturing,... ...Operations, Quality, Regulatory Affairs, Manufacturing, R&D, and... ...significant growth.EOE Statement: Specialist Staffing Group is an...Medical deviceWorldwide
- ...Regulatory Affairs SpecialistSupport global Regulatory Affairs activities for medical devices across product development and lifecycle management. Develop regulatory strategies and submission content for new submissions, renewals, variations, and amendments. Support regulatory...Medical deviceTemporary work
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