- Merck & Co. (North Wales, PA)
- Job Description Position Description: Senior Specialist , Financial Planning & Analysis Our company's mission is to be the world's premier research-intensive ... operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance (QA)… more
- West Pharmaceutical Services (Exton, PA)
- Sr . Specialist , RA Project Management Requisition ID: 66487 Date: Nov 9, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... and planet through our sustainability efforts. **Job Summary:** This Senior Specialist , Regulatory Project...execution of project objectives in line with regulatory affairs ( RA ) team's priorities.… more
- Jacobs (San Antonio, TX)
- …specialty services to support our clients and projects. We're seeking a Certified Value Specialist (CVS) Project Manager in Texas. As a member of our team, ... Degree in Engineering or Architecture * Professional Registration (PE) or Registered Architect ( RA ) * Certified Value Specialist (CVS) Certification * 10+ years… more
- Amazon (Sunnyvale, CA)
- …Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr . Regulatory Affairs Specialist will be working to build ... Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS)… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …skills. 7. Ability to comprehend technical documents and concepts. **External-Facing Title:** Senior Specialist Regulatory Affairs **Posting Country:** ... **12271BR** **Title:** Sr . Specialist , Regulatory Affairs **Job...as sole representative from Regulatory to ensure regulatory compliance. + Depending on product/ project complexity,… more
- Fujifilm (Holly Springs, NC)
- …in Holly Springs, North Carolina, United States. **External US** **About This Role** The Sr . Specialist , Regulatory Affairs , provides critical insights ... project teams, guiding efforts to maintain manufacturing flexibility with minimal regulatory impact. Sr . Specialist establishes and maintains the site… more
- Medtronic (Minneapolis, MN)
- …more safely and efficiently, with more predictable procedure times and outcomes. The ** Senior Regulatory Affairs Specialist ** develops strategies for ... ensure Cardiac Ablation Solution portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance with regulatory… more
- J&J Family of Companies (Cincinnati, OH)
- Senior Regulatory Affairs Specialist (Robotics &...In joining our growing regulatory team, the Sr . Regulatory Affairs Specialist ... Johnson & Johnson Medtech Surgery, is recruiting for a ** Senior Regulatory Affairs Specialist...be working on the robotics, instruments and accessories portfolio RA needs, working closely with exceptional engineering and clinical… more
- Medtronic (Lafayette, CO)
- …in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist ( Sr . RAS) is responsible for collaborating, ... EU MDR implementation. The Sr . RAS role translates regulatory requirements into project /product requirements and collaborates cross-functionally, while… more
- Globus Medical, Inc. (Audubon, PA)
- …possible. **Position Summary** **:** Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with ... Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps… more
- Kelly Services (Sunnyvale, CA)
- …1 year contract role **Overview** The Regulatory Affairs Senior Specialist is responsible for serving as the RA lead on product lifecycle management ... Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a...project teams. This role includes completing regulatory reporting assessments for anticipated manufacturing, facility, product, and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused ... and as part of a team. **Job Overview:** The Senior Regulatory Affairs Specialist...or project management. + Minimum 3 years Regulatory Affairs and/or Project Management… more
- Integra LifeSciences (Harrisburg, PA)
- …with the Company's Notified Bodies and regulatory inquiries regarding regulatory issues/questions. + Maintains Regulatory Affairs product files ... and/or ability required for this position. + Bachelor's degree in science, Engineering, Regulatory Affairs , or other technically related field. + Minimum of 8… more
- Florida Crystals Corporation (Boca Raton, FL)
- … compliance, specifically relating to New Product Development and existing products. The Regulatory Affairs Specialist will work with multiple relevant ... Operations, Packaging and others, to ensure product compliance. The Regulatory Affairs Specialist provides updates...simplify activities to the benefit of the customer. + PROJECT MANAGEMENT - Managing resources, time, money, and scope… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Sr . CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical ... regulatory landscape by contributing to the regulatory ...and all stakeholders informed of assessments, overall strategy, and project status + Works within the procedures and systems… more
- Astrix Technology (Los Angeles, CA)
- …One of our innovative clients who specializes in the Nutraceutical space is seeking a Sr . Regulatory Affairs Specialist (Global) to help expand ... Regulatory Affairs Specialist (Global)... Regulatory Affairs Specialist (Global) Regulatory ...on API related, IND/NDA, and 503A/503B. + Effectively communicate project needs and deliverables to upper management as needed.… more
- PNC (Philadelphia, PA)
- …to contribute to the company's success. As a Risk and Control Specialist Senior within PNC's Regulatory Affairs organization, you will be based in ... at the manager's discretion As an Risk and Control Specialist Senior , you will be responsible for...you will be responsible for managing and coordinating the regulatory exam lifecycle, which includes pre-exam work, coordinating and… more
- Abbott (Des Plaines, IL)
- …of DNA, RNA, and proteins at the molecular level. **What You'll Work On** As a ** Senior Regulatory Affairs Specialist ** , you'll support the ... role. Areas you will work on if hired: + ** Regulatory Compliance** : Understand and apply regulatory ...21CFR 820 and IVDR (EU) 2017/746. Skills Needed: + ** Project Management** : Create project plans and… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …the Senior Manager, Regulatory Affairs , Microbiology, the Staff Regulatory Affairs Specialist is responsible for the preparation of strategies ... for moderately to highly complex regulatory submissions required to market new or modified medical...making bodies and standards development organizations. Able to use project management tools to facilitate development and communication of… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** The Staff Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for ... regulatory submissions and registrations for complex new product development...of BDDS Molecular Diagnostics products with desired claims. Proficient project /people management skills, establishes/achieves schedules and milestones for functional… more
