- Integra LifeSciences (Plainsboro, NJ)
- …associate will perform all required duties in compliance with company policies, US Food and Drug Administration and DOT/IATA, ISO 13485, and other applicable ... accuracy in ORACLE. + Process all required receiving paperwork; affix all appropriate labeling to stock items. + Sort and distribute miscellaneous items received to… more
- George's, Inc. (Edinburg, VA)
- …production areas to withstand compliance with Safety and Suitable Support facility Food Safety/ Regulatory Compliance programs such as Hazard Analysis Critical ... None Preferred Knowledge of Good Manufacturing Practices (GMP's) through the Food and Drug Administration (FDA). Understanding/knowledge of HAACP principles.… more
- Boehringer Ingelheim (Ridgefield, CT)
- … Regulatory Affairs will act as primary company liaison with the US Food and Drug Administration . This role will develop comprehensive, well-thought through ... projects/products, including formal meetings, FDA review of registration packages, and labeling negotiations. + Establishes and implements US regulatory strategy… more
- Boehringer Ingelheim (Ridgefield, CT)
- …* Act as a company liaison with the US Food and Drug Administration . * Research information on regulatory CMC standards and departmental policies. * Provide ... Review Team (PLRT) and in collaboration with US RA Labeling Content, provide CMC regulatory support during...Pharmacy program Fellow should have basic understanding of: + Food , Drug and Cosmetic Act. + 21 CFR regulations… more
- Boehringer Ingelheim (Ridgefield, CT)
- …clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External ... Regulatory Strategy Document. + In cooperation with US/Global Labeling , provide project-related US regulatory input into...+ Act as a company liaison with the US Food and Drug Administration . + Provide analysis,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Other Requirements** + In-depth understanding of US Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and ... regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or… more
- Globus Medical, Inc. (Audubon, PA)
- …preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the US Food and Drug Administration (FDA) for class II and class III products. This ... and line extensions. + Assists in review of product labeling and marketing materials. + Provides regulatory ...product labeling and marketing materials. + Provides regulatory oversight of changes in manufacturing facilities, processes, and… more
- Globus Medical, Inc. (Audubon, PA)
- …and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. ... needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine… more
- Actalent (Belcamp, MD)
- …other duties as assigned. Essential Skills + Experience in food manufacturing regulatory affairs. + Knowledge of FDA, USDA labeling regulations, and FSMA ... You will play a critical role in ensuring compliance with food manufacturing regulatory requirements, maintaining essential documentation, and supporting… more
- Globus Medical, Inc. (Audubon, PA)
- …and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. ... needed for IDE and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performing routine… more
- Bath & Body Works (Columbus, OH)
- …to ensure product compliance with applicable Consumer Product Safety Commission, Food and Drug Administration , Federal Trade Commission, and Environmental ... and our planet to help the world live more fully. The Senior Attorney, Regulatory , will provide counsel to the Company's business teams on regulatory matters… more
- Abbott (Plymouth, MN)
- …Systems (EMS), and other regulatory requirements. + Complies with US Food and Drug Administration (FDA) and international regulations, other regulatory ... their lives. **The Opportunity** Abbott is seeking a passionate, experienced **Senior Regulatory Affairs Specialist** to join our team on-site in Plymouth, MN. In… more
- Family Dollar (Chesapeake, VA)
- …_The Opportunity_ In this role, you will be responsible for supporting regulatory compliance programs and initiatives, focusing on FDA regulations as they pertain ... to food safety and quality, including private label ...but are not limited to:_ + Assist in the administration of quality system processes, including but not limited… more
- Mount Sinai Health System (New York, NY)
- …proper food handling procedures and all sanitary guidelines according to regulatory agencies. Produces, portions, and dispatches all food items assigned to ... Mount Sinai Beth Israel and MS Downtown, B3W - Food Service Administration RV - BI, Mount...supervisors 3. Ensures quality, quantity, temperature and appearance of food produced meets departmental and regulatory standards… more
- City Winery (Atlanta, GA)
- …scheduling of all shifts + Monitorand ensure proper completion of administrative duties by Shift Supervisorsincluding logging, labeling , associate related ... We are a unique facility, combining a fully functioning winery with intimate concerts, food & wine classes, private events in a variety of configurations, and fine… more
- State of Montana (Helena, MT)
- …skills and abilities related to food processing technology, manufacturing processes, food labeling and nutritional labeling standards, FDA and USDA ... May develop and implement education and training programs for regulatory environmental and public health compliance. This specific position...to staff within the bureau on a number of food safety related topics as well as conducting FSA's… more
- F & S Fresh Foods (Riverside, CA)
- …Additional duties include: + Supervises QA and Production team members to ensure regulatory compliance in QA and Food Safety processes, adherence to protocols ... creating endless possibilities for our diverse customers-from restaurants and supermarket prepared food operations to convenience store chains and beyond. At F&S, we… more
- State of Indiana (Jasper, IN)
- … food defense, and other consumer protection statutory and regulatory requirements; controls unsafe or violative products through detentions, civil seizures, ... poultry products produced in their assigned establishment(s) using sound principles of food public health and food safety. The compliance officer investigates… more
- University of Miami (Miami, FL)
- …and submissions to entities such as the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). This role is essential for ensuring ... from protocol development and initiation to study close-out according to regulatory /sponsor guidelines, assures each study's integrity, and mentors less experienced… more
- Sutter Health (Santa Rosa, CA)
- …drug laws as regulated by the state board of pharmacy, the drug enforcement administration , and the food and drug administration by monitoring nursing ... (TJC), Title XXII, United States Department of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and United… more
