Global Regulatory Affairs Specialist - Medical Devices
Nihon Kohden Orange Med
Nihon Kohden Orange Med is seeking a Regulatory Affairs Specialist to coordinate global product registrations and regulatory submissions across markets. The role ensures timely documentation, maintains records, and collaborates with cross‑functional teams to meet regulatory requirements. The successful candidate will manage FDA 510(k) submissions, monitor regulatory changes, and provide support for post‑market activities, labeling, and compliance throughout the product lifecycle. #J-18808-Ljbffr Nihon Kohden Orange Med
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Specialist - Medical Devices in Santa Ana, CA vacancy
- Nihon Kohden Orange Med is seeking a Regulatory Affairs Specialist to coordinate routine regulatory activities across domestic and international markets, supporting product registrations, submissions, and post-market requirements. You will manage regulatory information,...Medical device
$80k - $95k
...Regulatory Affairs Specialist The Regulatory Affairs Specialist is responsible for coordinating and... ...that 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 shiftNIHON KOHDEN OrangeMed
Santa Ana, CA3 days ago$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... ...team partners across regulatory, quality, engineering... ...Senior Regulatory Affairs Specialist supports regulatory... ...neurovascular medical devices. This role is responsible...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$85.8k - $104.8k
...Job Description: The Regulatory Affairs Specialist creates, evaluates and completes regulatory... ...individual is responsible for obtaining global regulatory registrations/approvals... ...of Regulatory Affairs experience in medical devices or other regulated industry. We will...Medical deviceContract workWork at officeWorldwideFlexible hoursenVista
Brea, CA2 days ago$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... .... As a Regulatory Affairs Specialist, you will develop and... ...pharmaceutical or medical device industry...Medical deviceLocal areaFlexible hours- The Kardion Regulatory Affairs team is seeking a high energy, driven individual... ...Regulatory Affairs Specialist is a senior technical expert... ...for Class III cardiovascular medical devices. In this highly visible... ...ensuring alignment across global stakeholders and timelines....Medical deviceFull timeContract workRemote work3 days per week
$92k - $138k
...here. Medtronic is a global leader in healthcare... ...developing innovative medical technologies that improve... ...team partners across regulatory, quality, engineering... ...Senior Regulatory Affairs Specialist supports regulatory... ...neurovascular medical devices. This role is responsible...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hoursMedtronic
Irvine, CA10 days ago$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... ...As a Regulatory Affairs Specialist III, you will help ensure critical... ...degree in Biology, Chemistry, Medical Technology, or a related...Hourly payTemporary workMonday to FridayManpower
Irvine, CA3 days ago$90k - $120k
...Description Job Description Regulatory Affairs and Quality Assurance Specialist Location: Huntington Beach, CA... ...safe, reliable, and innovative medical devices that improve patient outcomes.... ...critical in ensuring compliance with global regulatory requirements and...Medical deviceFull timeSprintRay
Huntington Beach, CA29 days ago- 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
$95.8k - $159.6k
...or OnsiteSenior International Regulatory Affairs SpecialistIrvine, CAJoin a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this... ...working with medical devices or other regulated healthcare...Medical deviceFull timeFor contractorsLocal area- ...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
$61.12k - $95.39k
...About Us Össur is a leading global provider of innovative mobility... ...The Role The Compliance Specialist is responsible for assisting... ...compliance program for Embla Medical’s Americas Business Units. This... ...regulations that impact medical device companies such as anti-kickback...Medical deviceFull timeWork experience placementLocal areaEmbla Medical
Irvine, CA14 hours ago$80k - $110k
...Regulatory Affairs Specialist The Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history... ...capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory...Medical deviceWork experience placementLocal areaWorldwideFlexible hoursMasimo
Irvine, CA4 days ago- ...Head of Global Regulatory Strategy About the Company Global biopharmaceutical company leading... ..., and providing oversight for medical device programs. This role requires a seasoned... ...with a minimum of 15 years' regulatory affairs experience, including at least 10 years...Medical device
$92k - $130k
...world. From design to production, our Regulatory Affairs teams help guide our innovative technologies... ...impact of proposed and current global regulations and proposing suggestions... ...understanding of global regulations relevant to medical devices, Class II and/or Class III devices...Medical deviceFull timeWork experience placement$95.8k - $159.6k
...Senior International Regulatory Affairs Specialist Irvine, CA Join a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role... ...working with medical devices or other regulated healthcare...Medical deviceFull timeLocal areaStryker
Irvine, CAa month ago$40 - $46 per hour
Sr. Technical Recruiter | Talent Acquisition | Medical Device, Biotech, Life Sciences, Engineering, Regulated... ...Industries This is an exciting opportunity to join a Global, industry leading company as a Trade Compliance Specialist. Responsibilities Generate SAP reports to...Medical deviceHourly pay$182k - $346k
...building a deep understanding of the global market landscape, trends, customer... ...relationship with leaders across r&d, regulatory/legal, medical affairs, market research, operations,... ...experience in pharmaceuticals or medical devices, with experience in medical aesthetics...Medical deviceAbbVie
Irvine, CA2 days ago- Company & Job Overview Diality is a medical device company focused on developing solutions to improve lives impacted by kidney... ...of any professional dialysis care setting. The Principal Regulatory Affairs Specialist will serve as a key contributor responsible for authoring...Medical deviceWork at office
$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...Medical deviceFull timeWork experience placementLocal area$178k - $307.05k
...the best talent for a Senior Director, Global Strategic Marketing & Innovation... ...multiple functions including R&D, Clinical, Regulatory Affairs, Medical Affairs and Supply Chain among others.... ...(Master’s, MBA, or equivalent)Medical device industry experience is strongly...Medical deviceFull timePrivate practiceLocal areaImmediate startWorldwide$100.3k - $122.6k
...SummaryReporting to the Director, Kerr Global Markets, the Global Markets... ..., Marketing, Clinical Affairs, and local commercial teams... ...conditions, channels, and regulatory requirements.Support local... ...QualificationsExperience in dental, medical devices, healthcare, infection...Medical deviceFull timeContract workWork at officeLocal areaRelocation$178k - $307.05k
...Finance Director to lead EP US/Canada and Global Neurovascular. Reporting to the CFO of... ..., corporate policies and applicable regulatory requirements.Ability to work in a fast-... ...partnering in MedTech or related healthcare/medical devices environments.At least 5 years of people...Medical deviceFull timeTemporary workLocal areaImmediate start$24 per hour
...Johnson is rapidly expanding and is immediately hiring qualified Medical Device Assemblers to support production demand and new product... ...treatment of heart rhythm disorders. Johnson & Johnson is a global leader in cardiac electrophysiology, providing advanced catheter...Medical deviceTemporary workLocal areaImmediate startWorldwideDay shiftKelly Services
Irvine, CA10 days ago$122k - $212.75k
...Deliver product team within the Global Vision ERP product group and... ..., pharmaceutical, and medical devices and diagnostics markets. There... ...partners.Balance customer value, regulatory needs, technical feasibility... ..., architects, functional specialists, and suppliers to deliver...Medical deviceFull timeTemporary workLocal areaImmediate start$128.3k - $156.8k
...dynamic, strategic, and results-oriented Global Sr. Manager, Procurement to lead and... ...operations across a growing global medical device organization.This leader will develop... ...collaborate closely with Operations, Quality, Regulatory Affairs, R&D, Engineering, Finance, and...Medical deviceFull timeContract workWork at office$178k - $307.05k
...Description:The Senior Director, Global Demand & Americas End‑to‑End... ..., Procurement, Quality, Regulatory, and Finance.This leader is... ...management experience.Experience in medical device, healthcare, or regulated... ...with Quality and Regulatory Affairs to ensure compliance and...Medical deviceFull timeLocal areaImmediate startJohnson & Johnson
Irvine, CA10 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Affairs Specialist - Medical Devices. Be the first to apply!
Related searches
- regulatory law Santa Ana, CA
- regulatory technician Santa Ana, CA
- regulatory Santa Ana, CA
- regulatory engineer Santa Ana, CA
- clinical research regulatory Santa Ana, CA
- regulatory contract Santa Ana, CA
- food regulatory Santa Ana, CA
- medical device Santa Ana, CA
- compliance technician Santa Ana, CA
- ethics compliance Santa Ana, CA