- Edwards Lifesciences (Irvine, CA)
- **Job Description:** The Sr. Labeling Specialist , Localization will partner with vendors and internal stakeholders on translation projects to ensure timely ... PO's and management of other localization related documents and procedures. The Sr. Labeling Specialist , Localization will support new product launches and base… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …with domestic and international regulatory requirements with a specific focus on labeling and labeling requirements. **Primary Responsibilities:** + Act as ... for specified key products/facilities/equipment with a main focus in labeling and labeling related activities. + Manage and prepare complex submissions to… 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
- 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...Organizes and maintains RA files. + Reviews and approves labeling (Instructions for Use, labels, promotional materials) for compliance… more
- Caring Transitions (Winston Salem, NC)
- …a smooth and stress-free relocation experience. We are seeking a dedicated and experienced Senior Relocation Specialist to join our team in Winston Salem, NC. As ... a Senior Relocation Specialist , you will be responsible...**Responsibilities:** + - Coordinate and oversee the packing and labeling of belongings, ensuring items are handled with care… more
- ICU Medical (Lake Forest, IL)
- *Position Summary* The Senior Clinical Specialist (RN) provides clinical support to internal and external customers and provide the voice of the customer and to ... and applicability of products. The primary function of the Senior Clinical Specialist is to support the...Medical input in the development and execution of product labeling . Provide clinical input for on-market product issues… more
- Abbott (Alameda, CA)
- …Abbott shape the future of healthcare. As an individual contributor, the ** Senior Regulatory Affairs Specialist ** will support product development and regulatory ... review in support of "next-gen" product offerings. + Evaluate proposed design, labeling , and distribution changes for regulatory impact and implement any required… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Prepares global resources in collaboration with local affiliate teams (TA specialist team). + Identifies, reports, and records adverse events and product ... collaborates with cross-functional colleagues to respond to complex requests. TA specialist responds to complex requests from affiliate MI and internal colleagues… more
- Stryker (Denver, CO)
- …our award-winning organization by visiting stryker.com We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our Sport Medicine business ... of reports, metrics, proposals, and presentations. **What you will do** As the ** Senior Regulatory Affairs Specialist ** , you will support product development… more
- Medtronic (Miami Lakes, FL)
- Senior Regulatory Affairs Specialist - Mechanical Circulatory Support (hybrid) Join a diverse team of innovators who bring their worldview, their unique ... leader in medical technology and solutions. Careers That Change Lives The Senior Regulatory Affairs Specialist (Sr. RAS)develops and executes strategies for… more
- Abbott (Alameda, CA)
- …the way people monitor their glucose levels with our new sensing technology. The Senior Specialist Quality Assurance participates as a lead member of the ... verification, validation, use, and maintenance of medical device software. The Senior Specialist Quality Assurance will also coordinate activities with… 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 ... are developed and launched with precision. **What you will do** As the ** Senior ** **R** **egulatory Affairs Specialist ** , you will evaluate the regulatory… more
- Edwards Lifesciences (Irvine, CA)
- …. **How you will make an impact:** As a Senior Specialist , International Regulatory Affairs, you complete and ... new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects, based on prior experience… more
- Bausch + Lomb (Rochester, NY)
- …requires the incumbent to prepare submissions, review and approve product labeling & advertising, support facility inspections and participate in other regulatory ... etc.) to facilitate the maintenance of product approvals. Review and approve labeling and advertising of B+L device products. Review and provide input on… more
- Zimmer Biomet (Warsaw, IN)
- …risk of proposed regulatory strategies and offers solutions. + Review proposed labeling for compliance with applicable US and international regulations. + Write, ... industry. Must have 3 years of experience with FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU. Must have 2 years of… more
- Vectrus (Sacramento, CA)
- …This position is physically located in Oakland, CA in support of LOGCAP Senior most experienced member of a team in receiving, storing, inventorying, and issuing ... Statement. + Mark identifying codes, figures, or letters on articles, using labeling equipment + Make adjustments to inventory/location of stored stock. May… more
- Edwards Lifesciences (Irvine, CA)
- …suggestions on utilizing regulatory updates to expedite approval process * Review labeling content product and process changes, and product documentation to assure ... regulatory requirements compliance, consistency, and accuracy * Other incidental duties **What you'll need (Required):** * Bachelor's Degree in a related field and 5 years of previous related experience OR * Master's Degree in a related field and 3 years of… more
- Cardinal Health (Fort Lauderdale, FL)
- …release, facilities and equipment, material controls, laboratory controls, packaging and labeling , and production & process controls. + Establishes and reports ... metrics related products and processes as deemed necessary by the Regional Quality Manager (RQM). + Ensures the site manufactures products to meet the requirements of 21 CFR 212 (cGMP). + Handles and ensures quality of documentation (control, retention, and… more
- Cardinal Health (Houston, TX)
- …release, facilities and equipment, material controls, laboratory controls, packaging and labeling , and production & process controls. + Establish and report metrics ... related products and processes as deemed necessary by the RQM. + Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP) + Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities +… more
- Cardinal Health (Rochester, NY)
- …release, facilities and equipment, material controls, laboratory controls, packaging and labeling , and production & process controls. + Establishes and reports ... metrics related products and processes as deemed necessary by the Regional Quality Manager RQM. + Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP). + Handles and ensures quality of documentation (control, retention, and… more