- LSI Solutions (Victor, NY)
- …devices. After all, our customer is ultimately the patient. JOB TITLE: Regulatory Specialist ( Labeling ) - Days 8:00AM to 5:00PM SALARY RANGE: $113,000 - ... Labeling All Regulatory Specialists I, II, III, and Senior - Labeling Area: Base Level from...Regulatory Affairs Certification (RAC) a plus, but not required. Senior Regulatory Specialist : + Bachelor or Master's… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** Senior Regulatory Affairs Specialist - hybrid - Covington, Georgia Urology and Critical Care (UCC) is an established and trusted ... drainage process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for...takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of… 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 ... to hire** **Overview:** We are seeking a Regulatory Affairs Specialist ( Senior Level) to ensure company compliance...Audits + Technical Writing and Documentation + Support UDI Labeling Projects + Managing and Driving All Aspects of… more
- Medtronic (Chicago, IL)
- …different cultures, genders, and points of view come together- everyone wins. The Senior Medical Safety Specialist (SMSS) is responsible for providing medical ... maintains proficient knowledge of assigned products and therapies, such as device design and function, product labeling , indications, mechanism of action, care… more
- Stryker (San Jose, CA)
- …We are currently seeking a ** Senior Staff Regulatory Affairs Specialist ... insights to drive continuous improvement in functions. **What you will do** As the ** Senior Staff Regulatory Affairs Specialist ** , you will play an integral… more
- Abbott (Pomona, CA)
- …mothers, female executives, and scientists. **The Opportunity** The position of ** Senior Regulatory Affairs Specialist ** is within our Toxicology Business ... contained in the Global Regulatory Information Database + Provides recommendations on labeling , for regulatory compliance + Develops internal procedures and tools +… more
- Cambridge Isotope Laboratories, Inc. (Xenia, OH)
- …Isotope Separations (CIS) has an outstanding opportunity for an experienced Quality Assurance Senior Specialist based onsite in our Xenia, OH location. CIS is ... located at its CIS facility. Summary: Primary responsibility of the GMP Quality Assurance Senior Specialist is to work as a team member to uphold compliance… more
- Medtronic (Minneapolis, MN)
- …and efficiently, with more predictable procedure times and outcomes. The ** Senior Regulatory Affairs Specialist ** develops strategies for worldwide product ... regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, … more
- Bristol Myers Squibb (Summit, NJ)
- …Read more: careers.bms.com/working-with-us . **PURPOSE** **AND SCOPE OF POSITION** The Sr. Specialist IT, Cell Therapy Manufacturing Systems, plays a crucial role in ... manufacturing system-related problems, including building, testing, documenting, and implementing design changes. **REQUIRED COMPETENCIES** + Effective communication with both… more
- Medtronic (Boulder, CO)
- …in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning ... classification of product in the US and/or EU. + Design Dossier and/or Technical Documentation experience + Technical Writing...include FDA and EU (specifically EU MDR) + Product Labeling requirements and standards + May have practical knowledge… more
- Abbott (Plymouth, MN)
- …on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist ** to join our team on-site in ... new or modified, are distributed to appropriate personnel. + Reviews device labeling for compliance with FDA submissions and applicable regulations. + Supports the… more
- Abbott (St. Paul, MN)
- …the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Senior Regulatory Affairs Specialist ** to join our team on-site in St. ... Mission:why we exist** Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for… more
- Edwards Lifesciences (Irvine, CA)
- …support. (eg, IDE's, PMA's, annual reports, 510(k)'s, STED's and CE marking design dossiers and technical files) * Monitor proposed and current global regulations ... suggestions on utilizing regulatory updates to expedite approval process * Review labeling content product and process changes, and product documentation to assure… more
- M. C. Dean (Vienna, VA)
- …VA** Apply Now (https://phg.tbe.taleo.net/phg04/ats/careers/v2/applyRequisition?org=MCDEAN&cws=62&rid=9799) The Senior Communications Specialist position ... Alarmed Protected Distribution Systems, Security Systems, and Audio Visual Systems. The Senior Communications Specialist will be expected to self-perform the… more
- Envista Holdings Corporation (Brea, CA)
- **Job Description:** **JOB SUMMARY** : The **Regulatory Affairs Specialist (RA Specialist )** creates, evaluates and completes regulatory tasks related to the ... ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. **PRIMARY DUTIES & RESPONSIBILITIES:**… more
- Fresenius Medical Center (Lawrence, MA)
- …and provide regulatory input into key quality system processes, such as design controls, change control, labeling and advertising, and others. ... Europe (CE Mark), Mexico, Asia, etc. + Communicate directly with senior management, economic operators, andregulatory agencieson all regulatory issues. + Monitor… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Staff Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for regulatory ... no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products… more
- Legrand NA (Canonsburg, PA)
- …EHS and financial objectives are attained. + Directs EH&S project(s) including project design and schedule to meet objectives and the development of short and ... systems and make internal and external presentations. + Collaborates effectively with senior and executive management to develop and implement current and annual… more