- Arthrex (Ave Maria, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... other status protected by law.Arthrex, Inc. is a global medical device company and a leader in...a work order. Responsible for ensuring correct and complete labeling of device packaging and cartons. Responsible… more
- DivIHN Integration Inc (Portland, OR)
- …Infant at 224 507 1261 Sivanesan at 224 369 0756 Title: MacOS Support Specialist Location: Portland, OR Duration: 6 Months (with possible extension or temp to ... to teams Document the lab layout and usage, processes, device info etc. so that it's easily accessible to...lab You must have experience in racking up servers, cabling/ labeling , building and maintaining an engineering labs with test… more
- Actalent (Minneapolis, MN)
- Labeling Specialist Job Description * Develop and...a fast-paced environment. Hard Skills + 3-5 Years of Medical Device Labeling + Technical Writing ... Manage Labeling : Create, revise, and maintain labeling , including user manuals, quick-start guides, labels, and other technical documents. * Regulatory… more
- Bausch + Lomb (Bridgewater, NJ)
- …relating to submissions and regulatory approval of medical devices. Knowledge of medical device product labeling processes for review and obtaining ... + Other duties as assigned. **Requirements** **TECHNICAL COMPETENCIES:** Knowledge of medical device regulatory affairs discipline throughout the product… more
- LSI Solutions (Victor, NY)
- …in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive ... passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS(R)...our customer is ultimately the patient. JOB TITLE: Regulatory Specialist ( Labeling ) - Days 8:00AM to 5:00PM… more
- STERIS (Mentor, OH)
- … is a multi-faceted position encompassing the development and maintenance of medical device product labeling , informational and instructional literature, ... Product Labeling Specialist Req ID: 44025 Job...+ Responsible for supporting the development and maintenance of medical device product labeling , informational… more
- Aston Carter (Thousand Oaks, CA)
- …in pharmaceuticals, natural science or medicine * Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling * Knowledge ... document control, quality systems management, regulatory documents, regulatory compliance, medical device Top Skills Details: labelling,regulatory affairs,regulatory,fda,gmp,pma,regulatory… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …experience. 2. A minimum of five (5) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation and ... **12360BR** **Title:** Sr Specialist , Labeling Design **Job Description:** Design, develop, and update global labeling documents to include product labels,… more
- Medtronic (Northridge, CA)
- …and other duties may be assigned. + Creates, reviews, and reproduces text required for labeling medical products. + Ensures that labeling , art, film, and ... Illustrator and/or other graphic design programs + Knowledge of US and international medical device regulations and standards, especially those related to … more
- Actalent (Minneapolis, MN)
- Labeling Specialist Job Description: We are seeking a highly motivated and organized Labeling Specialist to join our team. The ideal candidate will be ... 3-5 years of experience in technical writing or technical communications within the medical device industry. + Proficiency in Adobe InDesign and Microsoft Office… more
- ICU Medical (Lake Forest, IL)
- …or territory in good standing *Minimum 2 years experience required, preferable in medical device industry *Minimum 5 years of clinical experience *Physical ... the development of new and existing products for ICU Medical , Inc. The Clinical Specialist provides clinical... medical information inquires internally and externally *Provide Medical input in the development of product labeling… more
- Globus Medical, Inc. (Audubon, PA)
- …is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic medical devices; + ... At Globus Medical , we move with a sense of urgency...as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions,… more
- West Pharmaceutical Services (Exton, PA)
- …support submissions including Premarket Notifications, Technical Documentations under EU MDR ( Medical Device Regulation), and Master Files (DMF/MAF) associated ... Sr. Specialist , Regulatory Project Mgmt Requisition ID: 66496 Date:...skills, as well as demonstrated understanding of pharmaceutical and/or medical device operations (eg, manufacturing, process development,… more
- Abbott (Plymouth, MN)
- …help of international regulatory affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with ... ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Kelly Services (Redondo Beach, CA)
- **Title** : Regulatory Affairs Specialist (Senior Level) **Pay** : $38-$50/hr depending on experience **Shift** : M-F, standard working hours. **Hybrid** role **Temp ... to hire** **Overview:** We are seeking a Regulatory Affairs Specialist (Senior Level) to ensure company compliance with US FDA 510(k), Health Canada Licensing,… more
- Actalent (Camarillo, CA)
- …Skills: labeling , regulatory comliance, FDA registrations, Regulatory affairs, Medical device , Regulatory, Regulatory documents, biology, gmp, biotech, ... Description: Summary The Regulatory and Compliance Specialist is responsible for initial new product assessment, confirming authorized distributors, NDC assignment,… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …Minimum of 4 years' experience in Regulatory (to include some experience within medical device ); experience in areas of product registration, compliance or ... **Job Description Summary** Senior Regulatory Affairs Specialist - hybrid - Covington, Georgia Urology and...+ Must have knowledge of the US and European medical device regulations. + Must have technical… more
- Kelly Services (Anasco, PR)
- …or Biomedical. + Minimum of 5 years of experience at the medical device and/or pharmaceutical manufacturing environment in manufacturing process, quality ... you. How about this one?** We're seeking **Project Validation Specialist ** to work with one of out top pharmaceutical/biotechnology...PLM system. + Must have knowledge of European Union Medical Device Regulation (EU MDR 2017/745), European… more
- Medtronic (Minneapolis, MN)
- …minimum of 5 years of relevant experience + Or minimum 5 years of medical device regulatory affairs experience with Master's degree **Preferred experience:** + ... affairs support for Class I, II and Class III medical devices. The Sr Principal Regulatory Affairs Specialist...4+ years of medical device industry experience with US FDA… more
- Fresenius Medical Center (Lawrence, MA)
- …+ 8+ years' experience in domestic and international Regulatory Affairs in the medical device industry + Experience interacting with FDA regarding regulatory ... matters + Expertise in working within Medical Device Regulations including Quality System Regulation 21 CFR Part 820, ISO 13485, EU MDD/MDR, Canadian Regulations… more
