- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... with overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director. Works with personnel in other departments… more
- Edwards Lifesciences (Irvine, CA)
- …of other localization related documents and procedures. The Sr. Labeling Specialist , Localization will support new product launches and base business ... **Job Description:** The Sr. Labeling Specialist , Localization will partner with vendors and internal stakeholders on translation projects to ensure timely… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …formulate regulatory strategy for changes to products/facilities/equipment with an impact on product labeling . + Evaluate impact of new regulatory requirements ... as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary. + Mentor and support the… more
- Integra LifeSciences (GA)
- …possible and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible for contributing ... in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing advanced level regulatory input for regulatory documentation… more
- Medtronic (Mounds View, MN)
- Senior Regulatory Affairs Specialist - Cardiac Surgery (hybrid) Cardiac surgery represents end stage treatment in the care continuum for many cardiovascular ... leader in medical technology and solutions. Careers that Change Lives The Senior Regulatory Affairs Specialist is responsible for developing regulatory… more
- Stryker (Allendale, NJ)
- …More information is available at www.stryker.com We are currently seeking a ** Senior Staff Regulatory Affairs Specialist ** to join our **Spine Division** ... regulations and expectations. **What you will do** As the Senior Staff Regulatory Affairs Specialist , you will...process. + Provides regulatory information and guidance for proposed product claims/ labeling . + Ensures that the clinical… more
- Stryker (Raleigh, NC)
- …More information is available at www.stryker.com We are currently seeking a ** Senior Staff Regulatory Affairs Specialist ** to join our **Neurovascular Division** ... is complete and meets regulations and expectations. **What you will do** As the Senior Staff Regulatory Affairs Specialist , you will work to maintain medical… more
- Stryker (Fremont, CA)
- …our award-winning organization by visiting stryker.com We are currently seeking a ** Senior Staff Regulatory Affairs Specialist ** to join our Neurovascular ... to continuously improve. **What you will do** As the ** Senior Staff Regulatory Affairs Specialist ** , you..., you will be core team member of new product development team and review advertising and promotional materials.… more
- ICU Medical (Lake Forest, IL)
- …internally and externally . Provide Medical input in the development and execution of product labeling . Provide clinical input for on-market product issues ... *Position Summary* The Senior Clinical Specialist (RN) provides clinical...customer and clinical experience for design input with new product development and product lifecycle management .… more
- Stryker (Denver, CO)
- …presentations. **What you will do** As the ** Senior Regulatory Affairs Specialist ** , you will support product development activities on cross-functional ... organization by visiting stryker.com We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our...process + Provides regulatory information and guidance for proposed product claims/ labeling + Ensures that the clinical… more
- Stryker (Mahwah, NJ)
- …our award-winning organization by visiting stryker.com We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our Joint Replacement Division ... launched with precision. **What you will do** As the ** Senior ** **R** **egulatory Affairs Specialist ** , you...process + Provides regulatory information and guidance for proposed product claims/ labeling + Ensures that the clinical… more
- Chenega Corporation (Washington, DC)
- **Req ID:** 31189 **Summary** ** Senior Government Information Specialist SME (Privacy)** **Hybrid Schedule: In person, in the Washington, DC office twice a pay ... offices; and additionally utilizes resources from numerous cloud providers. The ** Senior Government Information Specialist SME (Privacy)** ensures compliance… more
- Medtronic (Mounds View, MN)
- …solutions. Careers That Change Lives The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory ... Senior Regulatory Affairs Specialist - Cardiac...+ Prepare worldwide submissions for new products and their product changes as required to ensure timely approval for… more
- Abbott (Alameda, CA)
- …healthcare. As an individual contributor, the ** Senior Regulatory Affairs Specialist ** will support product development and regulatory activities to ... compliance with product post marketing requirements + Review product labeling to ensure compliance with relevant regulatory requirements. + Individual may… more
- MyFlorida (Homestead, FL)
- SENIOR SANITATION AND SAFETY SPECIALIST - 42003434 1(FOR INTERNAL AGENCY EMPLOYEES ONLY) Date: May 22, 2024 Location: HOMESTEAD, FL, US, 33032 MIAMI, FL, US, ... . Requisition No: 829809 Agency: Agriculture and Consumer Services Working Title: SENIOR SANITATION AND SAFETY SPECIALIST - 42003434 1(FOR INTERNAL AGENCY… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Support departmental strategic initiatives to address major activities within TA ( product launches, labeling updates, patient engagement, etc.) + Execute and ... + Prepares global resources in collaboration with local affiliate teams (TA specialist team). + Identifies, reports, and records adverse events and product… more
- Edwards Lifesciences (Irvine, CA)
- …. **How you will make an impact:** As a Senior Specialist , International Regulatory Affairs, you complete and ... teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling... product and process changes, and review of labeling content and guidance on process improvement projects, based… more
- Bausch + Lomb (Rochester, NY)
- …This position requires the incumbent to prepare submissions, review and approve product labeling & advertising, support facility inspections and participate in ... reports, change notifications, etc.) to facilitate the maintenance of product approvals. Review and approve labeling and...maintenance of product approvals. Review and approve labeling and advertising of B+L device products. Review and… more
- Actalent (Bedford, MA)
- …appropriate). Educate and train IL personnel on international country registration and labeling requirements to ensure that during product development, their ... Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output. Prepare new product … more
- Zimmer Biomet (Warsaw, IN)
- …leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will ... risk of proposed regulatory strategies and offers solutions. + Review proposed labeling for compliance with applicable US and international regulations. + Write,… more
