Global Regulatory Affairs Specialist - Medical Devices
Nihon Kohden OrangeMed, LLC
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, collaborate with internal teams, sales offices, distributors, and regulatory partners, and escalate complex issues as needed while ensuring compliance throughout the product lifecycle.
#J-18808-Ljbffr- ...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...Medical device
$80k - $95k
...become available. Job Purpose The Regulatory Affairs Specialist is responsible for coordinating and... ...support the company’s worldwide medical device business. This position supports product... .... Duties and Responsibilities Global Product Registrations and Regulatory...Medical deviceWork at officeWorldwideWeekend workAfternoon shift- ...Senior Regulatory Affairs Specialist Overview Join a growing neurovascular medical device team supporting regulatory compliance and product lifecycle activities for innovative... ..., clinical, and commercial teams to support global regulatory strategy and market access. Key...Medical device
$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$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$80k - $100k
...at the speed of life. Masimo is a global medical technology company that develops and... ...makes everything possible. The Regulatory Affairs Specialist is responsible for obtaining domestic... ...regulatory assessments of medical device regulations to help effective application...Medical deviceWork experience placementWorldwide$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 hours$89.2k
...Diversity - Innovation - Caring - Global Collaboration - Winning... ...individual for a Senior Regulatory Affairs Specialist position (hybrid work mode)... ...growing active implantable device portfolio. This role will be... ...Affairs experience in the medical industry Prior experience...Medical deviceHourly payWork at officeLocal areaRelocationShift work3 days per week$74k - $104k
...Edwards Lifesciences seeks a Regulatory Affairs Specialist to support corporate... ...process improvements across global operations. The role involves... ...regulatory changes, managing device listings and registrations,... ...alternatively Knowledge of medical device regulations and...Medical deviceWork at officeWorldwide$80k - $100k
...the speed of life. Masimo is a global medical technology company that develops and... ...makes everything possible. The Regulatory Affairs Specialist is responsible for obtaining domestic... ...regulatory assessments of medical device regulations to help effective application...Medical deviceFull timeWork experience placementWorldwide$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 Friday$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 time- 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
- ...in California is seeking a Director of New Product Introduction to drive global supply chain readiness for new products from concept to commercialization. You will partner with BU, R&D, regulatory, and manufacturing to align plans, manage risk, and lead complex launches...Medical device
- ...a Director of Procurement for a rapidly growing medical device company in the Irvine area. The role leads global sourcing, supplier management, and contract manufacturing... ...and partner with Engineering, Quality, Regulatory, Operations, and Finance to build scalable procurement...Medical deviceContract work
$185k - $240k
A leading medical device company located in California is seeking a Director of Global Commercial Training. The role involves directing and overseeing commercial employee training programs to enhance effectiveness and ensure onboarding support. Candidates should possess...Medical device- ...Head of Global Regulatory Strategy About the Company Global biopharmaceutical company developing... ..., and providing oversight for medical device programs. This role requires a seasoned... ...a minimum of 15 years' regulatory affairs experience, including at least 10 years...Medical device
$32 - $36 per hour
...Regulatory Affairs AssociateLocation: Tustin, CA Schedule: Monday–Friday, 9:00 AM–5:00 PM Pay: $32–$36 per hour, based on experience and... ...career in regulatory affairs within the biotechnology and medical device industry.The ideal candidate will be detail-oriented, organized...Medical deviceHourly payTemporary workWork at officeMonday to Friday- ...Principal Regulatory Affairs SpecialistDiality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality... ...care setting.The Principal Regulatory Affairs Specialist will serve as a key contributor responsible for authoring...Medical deviceWork at office
- ...forecasting, analytics, and competitive intelligence for the global electrophysiology business. The role synthesizes internal and... ...market models Strong business acumen and understanding of medical device or healthcare markets Executive-level communication skills...Medical device
$61.12k - $95.39k
...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... ...that impact medical device companies such as anti-kickback...Medical deviceFull timeWork experience placementLocal 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
- ...coordinating planning processes, and aligning methodologies across global teams. Responsibilities Own P&L modeling for Allergan... ..., or related field ~12+ years in pharmaceutical, biotech, medical device, consumer health, or life sciences finance and forecasting ~...Medical device
$92k - $130k
...Edwards Lifesciences seeks a Senior Specialist in Regulatory Affairs for its Transcatheter Heart Valve... ...compliance, and preparing submissions to global agencies. Requires a bachelor's... ...and expertise in Class II/III medical device regulations. Responsibilities...Medical device$80k - $100k
...Regulatory Affairs Specialist at Masimo, a Danaher medical technology company, manages domestic and international regulatory clearances for medical devices. The role involves preparing submissions, coordinating with regional teams, and ensuring compliance with regulatory...Medical deviceWorldwide$130k - $155k
Job Description:Global Product ManagerAt Kerr, we're passionate about creating innovative... ....Partner closely with R&D, Regulatory Affairs, Operations, Procurement, and Commercial... ...Product Management experience within the medical device industry.Proven success managing the full...Medical deviceFull timeContract workWork at officeWorldwideRelocation$92k - $130k
...Senior Specialist in International Regulatory Affairs supporting the Transcatheter Mitral and Tricuspid Therapies... ...and provide strategic guidance on global compliance pathways.... ...preparing domestic and international medical device submissions Knowledge of global...Medical deviceOverseas$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- ...Stark Pharma Solutions Inc. is a global consulting and staffing partner established... ...in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the... ...solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project...Medical device
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