- Legend Biotech USA, Inc. (Raritan, NJ)
- …in science or related fieldA minimum of one (1) year related experience in medical device , biopharmaceutical, or pharmaceutical industryMust be able to work 2nd ... OverviewThe QC Technician is responsible for QC sample labelling process. The QC Specialist is encouraged to work independently on routine tasks and have conceptual… more
- Abbott (Sylmar, CA)
- …The ** Labeling Specialist ** is responsible for the development of medical device labeling for the Division by coordinating across functions ... that they meet all medical , legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines and… 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
- Kelly Services (Bridgewater, NJ)
- …of industry experience with applied knowledge of applicable standards, regulations of medical device labeling requirements. **Requirements** **What happens ... **Global Labeling Lead Specialist ** Kelly(R) Science &...leading labeling artwork development/ revisions projects for medical device products, and assessing changes in… more
- Edwards Lifesciences (Irvine, CA)
- …enables clinicians around the world to enhance and save lives. The Associate Labeling Specialist role partners with business cross-functional project teams to ... of content management is a plus * Understanding of medical device design elements, experience with translations...* Moderate understanding of domestic development and implementation of labeling * Basic understanding of medical and/or… 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
- Zimmer Biomet (Jacksonville, FL)
- …of belonging. **What You Can Expect** This office position is responsible for leading medical device labeling projects (including, but not limited to product ... innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's...labels, IFUs, translations, labeling systems, and UDI initiatives) as necessary to market… more
- Actalent (Fridley, MN)
- …experience or advanced degree with no experience. + Experience in the development of labeling for the medical device industry is preferred. + Practical ... SpecialistJob Description We are seeking a dedicated and skilled Labeling Specification Specialist to join our dynamic...Responsibilities + Create, review, and reproduce text required for labeling medical products. + Ensure that … more
- Fujifilm (Twinsburg, OH)
- …please visit_ _healthcaresolutions-us.fujifilm.com_ _._ **External US** **Job Title** **: Medical Device Repair Technician** **Job purpose** This position ... + Perform other work as directed by Operations management, including repair/testing of other medical device components. + Comply with all applicable US Food and… 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 Management (Evergreen Posting) Requisition ID:...skills, as well as demonstrated understanding of pharmaceutical and/or medical device operations (eg, manufacturing, process development,… more
- Abbott (San Diego, CA)
- …responsible positions. **Preferred Qualifications** + 1-3 years in an IVD or medical device manufacturing environment + Good knowledge of federal regulations ... of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000...business unit has an opportunity for a Regulatory Affairs Specialist II which can be based in either San… 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
- Medtronic (Minneapolis, MN)
- …Bachelor's degree required + Minimum of 2 years of experience in regulatory affairs in the medical device industry + Or advanced degree with a minimum of 0 years ... strategies, and preparing US/EU submissions. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device ...of experience in regulatory affairs in the medical device industry. **Nice to Have (Preferred… more
- Amazon (Sunnyvale, CA)
- …- . Strong written, verbal, presentation, and organizational skills. - . Experience with medical device software requirements. - . Ability to identify risk areas ... TV and Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory...Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class… more
- Abbott (Sylmar, CA)
- …ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are ... or modified, are distributed to appropriate personnel. + Reviews device labeling and marketing materials for compliance...device regulations or with EU and other international medical device regulations and submissions. + Ability… 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
- Randstad US (Lake Forest, CA)
- …to five (5) years of work experience + Knowledge of US, EU, and Canada Medical Device Regulations + Familiarity with PLM WindChill and Veeva RIM platforms (not ... regulatory affairs specialist ii. + lake forest , california +...documentation that are required in situations such as proposed device changes or labeling changes. + Identify… more
- Fujifilm (Santa Ana, CA)
- …+ A minimum of 1-2 years of combined experience in clinical research, medical writing, clinical science in themedical device and/or pharmaceutical industry + ... innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing… more
- Medtronic (Minneapolis, MN)
- …profile_ + Bachelor's degree in a technical discipline + Minimum 4 years of medical device regulatory experience with Bachelor's degree + Or minimum 2 years ... predictable procedure times and outcomes. The **Senior Regulatory Affairs Specialist ** develops strategies for worldwide product registration with global...of medical device regulatory experience with an advanced… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …+ Coordinates/prepare and maintains CE files in accordance with current Medical Device Directive requirements, manages Essential Requirement checklists and ... in Regulatory Affairs or Regulatory Affairs Certification preferred + Experience with medical device regulatory submissions (510(k) or PMA preferred + Previous… more
