Global Medical Device Regulatory Affairs Specialist
envista
Envista is seeking a Regulatory Affairs Specialist to plan and manage global regulatory submissions for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role advises on regulatory strategy, assesses impact of design changes, and ensures compliance across markets. The position involves compiling submission packages, engaging with authorities, supporting audits, and maintaining SOPs to sustain efficient regulatory operations. #J-18808-Ljbffr envista
- 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
- 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...Medical device
- 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
- ...Description Job Description Sr. Regulatory Affairs Specialist 100% ONSITE in Westlake... ...for this role Caldera Medical’s Mission - To Improve the... ...and implement medical device regulatory strategies to... ...accurately prepared and comply with global regulations. The position...Medical deviceWork at officeLocal areaWorldwide
- JOB SUMMARY The Regulatory Affairs Specialist is responsible for planning, preparing, coordinating, and managing global regulatory submissions and registrations for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role represents...Medical deviceWorldwide
- ...is seeking a Program Manager (Program integrator) to manage global medical device and combination product programs from development through... ...plans, and driving milestones with a focus on quality and regulatory alignment. You will coordinate with engineering, quality, regulatory...Medical device
- 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
- ...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...
- 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
- 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
- ...accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to help support our teams... ..., creative talent, enthusiasm, and diligence. As a leading global Commissioning, Qualification, and Validation Services...Medical deviceHourly payPermanent employmentFull timeFor contractors
$20 - $21 per hour
...Description: We are looking for a precise, quality-driven Medical Device Assembler to join our 2nd Shift production team. In this role... ...maintaining a high level of dexterity, and adhering to strict regulatory standards are paramount. location: Agoura Hills, CA...Medical deviceHourly payTemporary workWork experience placementLocal areaAfternoon shift- ...organizational and communication skills, experience and 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 shortlisting to begin Weds 8/5 Must be local to...Medical deviceFull timeLocal area
- ...Description Job Description Regulatory Operations Specialist **on site in Westlake... ...option** Caldera Medical’s Mission - To Improve the... ...solutions. Our Regulatory Affairs team keeps that mission moving... ..., or a related medical device function — or a strong adjacent...Medical deviceFor contractorsLocal areaRemote workWorldwide
- ...submissions. ~ Experience working with Notified Bodies and global regulatory agencies for product approvals and compliance matters Our... ...Compensation, Comprehensive Benefits, and more! ~ Medical and Dental Benefits ~ Vision Coverage ~401(k) with 4% matching...Full timeLocal areaWorldwide
$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$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- 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
- ...development to production transfer, including verification, validation, and usability assessments. This on-site role in Thousand Oaks, CA requires a BS in Mechanical or Biomedical Engineering and 2+ years in regulated medical device development. #J-18808-Ljbffr envistaMedical 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- ...Thousand Oaks, CA is seeking a qualified Mechanical or Biomedical Engineer to lead New Product Development for surgical implants and medical devices, ensuring ISO 13485 compliance and FDA readiness. You will plan and execute Design Verification and Validation, conduct FMEA...Medical device
- ...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
$175k - $195k
...driving force behind everything we do. As a global leader with the most comprehensive... ...performing team of sales representatives and specialists through clear performance expectations,... ...Diagnostics, life sciences, pathology, medical device, or laboratory workflow experience....Medical deviceFull timeContract workRemote workWork from homeFlexible hoursNight shift- ...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
- ...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
$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
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