- Merck & Co. (North Wales, PA)
- …and Devices therapeutic areas. Acting as the single, accountable global point of contact, the Liaison provides strategic regulatory oversight to accelerate ... and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the leading edge… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) driving...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) providing...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… more
- Wolters Kluwer (Chicago, IL)
- …regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards. ... locations on the posting). **OVERVIEW** You will be the global product quality lead in support of a broad...in support of a broad portfolio of on-market medical devices including Software as a Medical Device … more
- Lilly (Indianapolis, IN)
- … Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA- Devices , GRA-RD&E, and GRA- Global Labeling and Product Communications. ... a global regulatory strategy which supports product (including delivery device and relevant medical devices ) development, registration, and lifecycle… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global...and updating of standards and processes related to drug, device , and biologics US AdPromo regulations and guidances. +… more
- Medtronic (Fridley, MN)
- …applying principles of safety risk management. + General working knowledge of applicable global medical device regulations, including FDA CFR 21, EU MDR, ISO ... world. **A Day in the Life** The Senior Medical Director for Medical Safety (MDMS) plays a critical role...voice for the patient, championing the optimization of medical device safety throughout the product lifecycle. This position supports… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the Device Engineering, Primary Container, Process Development, Packaging, and Labeling functions, and work closely with Strategy & Operations, Human Factors, ... aspirations. Join Gilead and help create possible, together. **Job Description** The Director , New Product Planning & Drug Delivery Innovation, will serve an… more
- Caldera Medical (Westlake Village, CA)
- …the Quality of Life for Women! Message from the Hiring Manager: The Director of Regulatory Affairs will lead global regulatory strategy, manage submissions, ... Director of Regulatory Affairs ONSITE in Westlake Village,...of progressive experience in regulatory affairs within the medical device industry. * Proven track record with global… more
- Actalent (Valencia, CA)
- …strategies to support product development, registration, and post-market compliance of medical devices , including Software as a Medical Device (SaMD). The role ... Job Title: Director of Regulatory AffairsJob Description The Director...preparation, submission, and management of regulatory filings for various global markets including the US, EU, Canada, Australia, and… more
- Lundbeck (Deerfield, IL)
- …advocacy, medical publications, and trial engagement materials. + Provide directions to global labeling processes, including inform decisions on Target Product ... Director Regulatory Affairs Alliance and Commercialization Requisition ID:...and expertise of regulations across scientific messaging, promotional compliance, global regulatory strategic labeling and regulatory strategy.… more
- System One (Malvern, PA)
- …with management responsibilities. + Strong understanding and experience with US and global regulatory requirements for class II medical devices including but ... Job Title: Director of Regulatory and Medical Affairs Location: Malvern,...and Medical Affairs SOPs to ensure full compliance with global regulatory requirements. + Maintain current knowledge of changes… more
- Edwards Lifesciences (Irvine, CA)
- …while minimizing potential legal risks. This role requires deep knowledge of global medical device -industry, including the regulatory landscape, authorities and ... adherence to various laws and regulations around the globe specific to medical device companies (eg, labeling regulations, anti-kickback laws, false claims laws,… more
- Bausch Health (Bridgewater, NJ)
- Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it ... values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and post-approval/regulatory compliance… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Description** **We are the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health (TM) is ... that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an… more
- Philips (Chicago, IL)
- …10+ years of experience working in Regulatory Affairs within the medical device industry; Experience with software-enabled medical devices , SaMD, AI, digital ... ** Director , Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)**...for the Ultrasound business. **Your role:** + Lead a global Regulatory Affairs team for end-to-end regulatory affairs input… more
- Stryker (San Jose, CA)
- …+ Review regulatory compliance requirements for changes affecting product submission and device manufacturing in global markets. + Implement regulatory system ... regulatory bodies/agencies. + Responsible for Technical Publications organization, ensuring compliant labeling (IFUs, labels, etc) and on-time support of New Product… more
- Abbott (Lake Forest, IL)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 colleagues serve people in… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 colleagues serve people in… more
- Abbott (San Diego, CA)
- …role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs. We're empowering smarter medical ... Abbott is a global healthcare leader that helps people live more...healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 colleagues… more
