- 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)
- …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
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …regulatory guidance for one or more program(s), including participation in external Food and Drug Administration (FDA) meetings, internal core team meetings ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional...synchronize domestic and international submissions. + Review and Approve Labeling and Advertising and Promotional materials for compliance to… 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
- Whitsons Culinary Group (Berkeley, IL)
- Director of Nutrition Services and Regulatory Compliance - Berkeley Culinary Center Berkely, IL, USA Requisition Number 15409 Location Berkely Il Job Description ... Director of Nutrition Services and Regulatory Compliance Are you a nutrition professional driven by...with all current USDA regulations, supporting field teams through administrative reviews. + Stay ahead of USDA, FDA, 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 + 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
- Teleflex (Wyomissing, PA)
- …Support regulatory compliance activities, including Health Canada license renewals, Food and Drug Administration (FDA) product device listings, establishment ... Sr. Regulatory Affairs Associate **Date:** Nov 24, 2025 **Location:**...* Knowledge and experience with design control, change assessments, labeling requirements, etc. * Experience and knowledge of Quality… more
- Abbott (Plymouth, MN)
- …Management Systems (EMS), and other regulatory requirements. Complies with US Food and Drug Administration (FDA) regulations, regulations and other ... than 160 countries. Job Description WHAT YOU'LL DO We are recruiting for a Regulatory Operations Specialist II, to join our team in the Plymouth, MN location. In… more
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