Global Regulatory Affairs Specialist - Medical Devices
Stryker
Stryker in Irvine, CA is seeking an International Regulatory Affairs professional to drive efficient, compliant global product registrations across diverse pathways. You will collaborate with global teams to influence submission strategies and ensure products meet regulatory expectations for patients worldwide. Responsibilities include evaluating regulatory classifications, advising cross-functional teams, preparing filings, monitoring authority interactions, and building relationships with #J-18808-Ljbffr Stryker
- 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
- 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
- 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
- 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
- ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity... ...growing active implantable device portfolio. This role will... ...partnership with our global R&D, manufacturing, clinical... ...Affairs experience in the medical industry Prior experience...Medical deviceWork at officeLocal area3 days per week
$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$110.1k - $183.4k
Irvine, CA In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse... ...years of regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or related regulated...Medical deviceTemporary workLocal areaFlexible hours- ...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
$43 - $48 per hour
...Now Hiring: Regulatory Affairs Specialist – Medical Devices Irvine, CA – Hybrid Onsite Tuesday, Wednesday & Thursday Pay: $43-$48/hr Required Qualifications... ...Regulatory Affairs professional to support global medical device regulatory activities, including new device...Medical deviceImmediate start- ...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
- ...Job Title: Regulatory Affairs Associate I - Skincare Location: Irvine, CA (Zip Code: 92612) Work... ...within cosmetics, OTC products, medical devices, or pharmaceuticals. Comprehensive onboarding... ...of international regulatory requirements to support global market expansion....Medical deviceLocal areaRelocation
- Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of documentation for medical...Medical device
$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- ...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 Specialist 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...Medical deviceWork at office
$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- 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
$80k - $95k
...positions become available. Job Purpose The Regulatory Affairs Specialist is responsible for coordinating and... ...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$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 areaWorldwide$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 hours$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- ...****@*****.*** PR Range: 33-43/hr DOEThis Regulatory Affairs Device role will be based in Irvine, CA and works with internal... ...and approval of manufacturing changes for Class IIb (EU) medical devices.Qualifications:Experience supporting new device...Medical device
- ...Aesthetics on LinkedIn. Job Description The Director, Global Allergan Aesthetics (AA) Forecasting is the interface between... ...~12+ years of relevant experience in pharmaceutical, biotech, medical device, consumer health, aesthetics, or life sciences, including...Medical deviceFull timeLocal area
- ...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 deviceFull timeTemporary workLocal area
$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 shift$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...Medical deviceFull timeWork at officeLocal areaEarly shift- ...social, e-commerce, PR, and global markets. Creative Strategy... ...driven aesthetics aligned with regulatory requirements. Partner with... ...remains compliant with medical-grade skincare regulations, global... ...but Not Required: Medical device or pharmaceutical creative experience...Medical deviceFreelanceWork at officeRemote workShift work
$120k - $150k
...20% About Kardion Kardion is a medical device company advancing innovative technology... ...headquarters in Irvine and strengthen our global operating model, we are seeking a... ...cross-functional partners in Quality, Regulatory, Clinical, R&D, Finance, and other teams...Medical deviceFull timeRemote work$150k - $258.75k
...MedTech is hiring a Director, Global Digital Marketing for its... ...with commercial, marketing, medical affairs, legal/compliance, IT, procurement... ...digital experiences meet regulatory, accessibility, privacy, and... ...within healthcare, medical device, pharmaceutical, or highly...Medical deviceContract workTemporary workLocal areaWorldwide$200k - $245k
...Kardion is a cardiovascular medical device company developing next-generation... ...Summary The Director, Global Information Technology... ...subject matter expert during regulatory inspections, notified body audits... .... Depth in one or more specialist areas within the scope of...Medical deviceFull timeCasual workShift work
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