- Philips (Washington, DC)
- …right fit if:** + You've acquired a minimum of 10+ years' experience in FDA Regulations, Global Regulatory Affairs, Policies and Standards within the Medical ... Device/Technology industry or Health Authority ( FDA ), with proven experience in Strategic Regulatory ...won't stop until everybody everywhere has access to the quality . healthcare that we all deserve. Do the work… more
- LSI Solutions (Victor, NY)
- …to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory approvals, while maintaining full Quality and Regulatory ... assigned quality management system training on schedule. + Perform regulatory intelligence monitoring on a regular basis, documenting and distributing results as… more
- Sanofi Group (Framingham, MA)
- …including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high- quality regulatory submissions, managing ... + Act as direct liaison with agencies like US FDA and EMA + Develop positive relationships with regulators...documentation and submissions** + Write, prepare, review, and approve regulatory CMC dossiers + Ensure dossiers meet quality… more
- Medtronic (Santa Rosa, CA)
- …for new and existing products, ensuring alignment with business objectives and regulatory requirements. + Collaborate with R&D, Quality , Clinical, and Marketing ... issues with agency personnel. + Assist in negotiations with FDA and/or international regulatory agencies on assigned...procedures to ensure quality system compliance and high- quality work. + Maintain regulatory documentation to… more
- Kelly Services (Dallas, NC)
- ** Regulatory Affairs Associate** **Location:** Dallas, NC **Department:** Quality Assurance & Regulatory Affairs **Reports To:** Director, Quality ... Affairs Salary - $70,000 - $85,000 **Position Summary** The Regulatory Affairs Associate supports the Quality Assurance...regulations that may impact the company. 2. Independently research regulatory information related to US FDA , USDA,… more
- Carrier (Beverly, MA)
- …Regulatory Intelligence & Monitoring** + Interpret and monitor global regulatory requirements (eg, CE/MDR, FDA , ISO standards, environmental/transport ... + Regulatory Affairs Certification (RAC) or equivalent professional certification + Regulatory Knowledge on US: FDA , FCC; EU: MDR, Radio Equipment Directive,… more
- Post Holdings Inc. (Lakeville, MN)
- …R\&D, and Quality teams. + Support commercialization efforts by ensuring regulatory readiness from concept to shelf. + Educate internal teams on competitive ... **Brand:** Post Consumer Brands **Categories:** Quality **Locations:** Lakeville, Minnesota **Position Type:** Regular Full-Time **Remote Eligible:** Yes **Req ID:**… more
- Reckitt (Evansville, IN)
- …Supports industry association activities related to US-manufactured products. + Drives regulatory processes to ensure timely FDA filing, registration (including ... high quality requirements within tight deadlines. + Understands the regulatory and political environment influencing the infant and young children nutrition… more
- ThermoFisher Scientific (Greenville, NC)
- …core regulatory dossiers, drives country-level customization strategies, and ensures high- quality responses to regulatory RFIs to support timely trial ... and clinical strategy. + Lead preparation for and participation in key regulatory interactions ( FDA , EMA, MHRA, PMDA, and other agencies). **Clinical Operations… more
- Cedars-Sinai (Los Angeles, CA)
- …fuels innovation and the gold standard of care we strive for. The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory ... reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing… more