Global Medical Device Regulatory Affairs Specialist
Implant Direct
Implant Direct in Thousand Oaks, CA is seeking a Regulatory Affairs Specialist to manage global regulatory submissions for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role represents Regulatory Affairs on cross-functional teams, provides regulatory strategy, assesses impact of design changes, and ensures ongoing compliance across markets while supporting audits and regulatory developments. #J-18808-Ljbffr Implant Direct
- Envista is seeking a Regulatory Affairs Specialist to plan, prepare, and coordinate global regulatory submissions for medical devices, including US 510(k) and EU documentation. You will work with cross-functional teams to assess regulatory impact of design changes and...Medical device
- Envista Holdings Corporation seeks a Regulatory Affairs Specialist to plan, prepare, and manage global regulatory submissions for medical devices, including US 510(k) and EU technical files. You will coordinate cross-functional teams, provide regulatory strategy, and ensure...Medical device
- Implant Direct, part of Envista Holdings, seeks a Regulatory Affairs Specialist to manage global regulatory submissions for medical devices from Thousand Oaks, CA. You will coordinate 510(k) filings, CE documentation, and international dossiers, working with cross-functional...Medical device
- ...Sr. Regulatory Affairs Specialist 100% ONSITE in Westlake Village, California... ...available for this role Caldera Medical's Mission - To Improve the... ...and implement medical device regulatory strategies to obtain... ...prepared and comply with global regulations. The position is...Medical deviceWork at officeLocal areaWorldwide
- DBA-Verwaltungs-Gmbh is seeking a Global Trade Specialist to lead compliance in the import and export of medical devices across the United States. The role involves managing customs processes, trade risk mitigation, and collaboration across various functions. The ideal...Medical device
$85.8k - $104.8k
## Implant Direct Regulatory Affairs Specialist (Thousand Oaks, CA)Applylocations: United States of America, California... ..., preparing, coordinating, and managing global regulatory submissions and registrations for medical devices, including US 510(k), EU technical documentation...Medical deviceWorldwide- Advanced Bio-Logic Solutions Corp seeks a Global Trade and Customs specialist to advance global trade compliance. You will classify commodities, manage documentation, and support compliance to help products reach global destinations. This role offers flex remote work with...Remote jobFlexible hours
- ...ECCN determinations, and export control activities for drug products and materials. This role supports global trade, ensuring accurate documentation and regulatory compliance. You will review shipments, perform EEI submissions, and conduct sanctions screening. Collaboration...
- Merck & Co. seeks a Sr. Associate Import/Export to support the Global Trade and Customs Excellence (GTE) function. The role covers policy and execution for imports and exports to ensure medicines are delivered on time, with flexible remote options or within commutable...Remote jobFlexible hours
- ResMed is seeking an experienced Global Trade Specialist to manage import/export of medical devices across America. You will lead trade compliance, classification... ...and export controls while collaborating with Regulatory Affairs, Legal, and Procurement. The role requires...Medical device
- Engineer - Biotech Medical Device (Lifecycle Management, Design Controls, Documentation) - (JP... ...with our direct client, a leading global biopharmaceutical company. Job Description... ...Quality, Design Engineering, Reliability, Regulatory, and Supply Chain to investigate...Medical devicePermanent employmentContract workWork at officeLocal areaImmediate startWork from home
- ...Regulatory Operations Specialist **on site in Westlake Village, CA - no remote option** Caldera Medical’s Mission - To Improve the Quality of Life for... ...solutions. Our Regulatory Affairs team keeps that mission... ...quality, or a related medical device function — or a strong...Medical deviceFull timeFor contractorsLocal areaRemote workWorldwide
- ...Amgen in Thousand Oaks is seeking a Director, Global Regulatory Lead for Obesity & Related Conditions to provide strategic regulatory leadership, shape cross‑functional decision making, and lead interactions with Health Authorities. You will develop global regulatory strategies...
$101.68k - $137.56k
...Sr. Associate, Nonclinical Regulatory Specialist What you will do Let’s do this... ...& Drug Metabolism), global and regional regulatory leads... ...intersection of science, regulatory affairs, and submission management.... ...contributions, group medical, dental and vision coverage,...Flexible hours$140k - $150k
...effectively. Solutions are sold in a wide range of industries globally, but the core focus is food safety. Headquartered in... ...service operations, or technical support within diagnostics, medical device, life sciences, or technology industries. Minimum 5 years...Medical deviceFull timeContract workTemporary workLocal area$85k - $127k
...experienced and knowledgeable Global Trade Specialist to join our Global Trade... ...the import and export of medical devices across America. This role... ...ability to navigate complex regulatory and supply chain... ...functions, including Regulatory Affairs, Supply Chain, Legal, and...Medical deviceRemote jobTemporary workWork experience placementFlexible hoursShift work- ...comfortability in a PM role for a very large/ global organization. Any candidates who also have medical product/ device and technical skills in addition to PM is a plus... ...team members across engineering, quality, regulatory, clinical, manufacturing, supply chain, and other...Medical deviceContract workLocal area
- 3key Consulting, Inc. seeks an Engineer - Biotech Medical Device for a 16-month contract in Thousand Oaks, CA. The role focuses on lifecycle... ...products. You will collaborate with Manufacturing, Quality, Regulatory, and Design Engineering to investigate product performance,...Medical deviceContract workWork from home
- Envista Holdings Corporation in Thousand Oaks, CA, is seeking a Product Development Engineer to advance New Product Development for surgical implants, prosthetics, and instruments. You will participate in concept development, design verification, validation, and transfer...Medical device
- Envista Holdings Corporation seeks a Product Development Engineer to drive New Product Development for surgical implants, prosthetics, and instruments. You will contribute to concept development, design, verification, validation, and transfer to production, collaborating...Medical device
$98.7k - $120.7k
...EngineeringMinimum 2 years’ experience in product development; medical device or another highly regulated industry is highly... ...conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening...Medical deviceFull timeContract work- ...Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other...Medical device
- ...Integrator) to support cross-functional medical device and combination product development... ...combination products, engineering, quality, regulatory affairs, clinical development, manufacturing,... ...processes. Experience coordinating global or large‑scale cross‑functional...Medical deviceContract work1 day per week
$79k - $119k
...involves driving execution of molding technologies, improving efficiency, and ensuring compliance with global quality and regulatory standards in the medical device industry. The role will also include collaboration with cross-functional teams, vendors, and management...Medical deviceTemporary workWork experience placementFlexible hoursShift work- ...Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15557) Thousand Oaks, CA Job Title: Engineer, Complaints Technical... ...a consulting engagement with our direct client, a leading global biotechnology company. automotive manufacturing and services...Medical devicePermanent employmentContract workLocal area
$19 - $22 per hour
...Description: If you have Cleanroom Assembly or Medical Device experience and you're looking for work ASAP then this is the position for... ...0 clients each year. Aerotek is an Allegis Group company, the global leader in workforce and business solutions. To learn more, visit...Medical deviceWeekly payContract workTemporary workImmediate startMonday to FridayShift work$211.41k - $286.02k
...while ensuring patient safety, worker safety and regulatory compliance across our global operations.This is a highly visible... ...Process Development, Quality, Manufacturing, Medical Device Engineering, Regulatory Affairs and EHSS.Influence enterprise decisions through...Medical deviceFull timeRemote workFlexible hours$168.39k - $227.83k
...containers, and drug-delivery device combination products, as they... ...(ISO 10993-17) for medical devices.Prepare and/or manage... ...categorize hazards according to the Globally Harmonized Standard (GHS) for... ...Support scientific work including regulatory compliance, trade...Medical deviceFull timeWork at officeRemote workFlexible hours- ...Engineer for a consulting engagement with our client, a leading global biotechnology company. Ideal Candidate: has hands-on... ...experience in regulated industries such as biopharma, biomedical, or medical devices. CAD/SolidWorks skills are a plus. Entry-level candidates...Medical devicePermanent employmentContract work
- Job Title: Engineer, Drug Delivery Device / Lab Testing & Troubleshooting - Biotech (JP15... ...combination products from development through global launch. The engineer will support... ...Experience working in a regulated laboratory, medical device, pharmaceutical, biotechnology, or...Medical devicePermanent employmentContract work
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