- Capgemini (Pittsburgh, PA)
- …Engineer to lead and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review ... more
- Lilly (Indianapolis, IN)
- …with, current local and international regulations, laws, guidances (for example, FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly ... more
- Stryker (Flower Mound, TX)
- …compliance through the maintenance of regulatory documentation and support review by FDA , Notified Bodies and other regulatory bodies. You are viewed as the ... more
- Boehringer Ingelheim (Ridgefield, CT)
- …two (2) specialized areas of pharmaceutical law, one of which must be FDA Regulatory (eg, Transactions, FDA Regulatory, Commercial, Litigation, Clinical Trials, ... more
- University of Pennsylvania (Philadelphia, PA)
- …clinical trials + Participate in the conduct of study audits by sponsors,CRO's, the FDA and other entities as required. + Participate in the conduct of study audits ... more
- Mentor Technical Group (TX)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... more
- Integra LifeSciences (Princeton, NJ)
- …on time and in full compliance with relevant regulations (eg, ISO 13485, FDA QSR). + Prepare and present accurate metrics, quality trends, and other relevant ... more
- Lilly (IN)
- …with current local and international regulations, laws, guidance's (for example, FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly ... more
- GE HealthCare (Arlington Heights, IL)
- …requirements and that all documentation is in place to meet cGMP and FDA regulations. + Continuously assess and improve materials management processes to drive ... more
- UCLA Health (Los Angeles, CA)
- …investigational pharmacy applications, other ancillary services applications, FDA IND/IDE/510k/SAE/MedWatch applications and submissions, etc. + analytical ... more
- Regeneron Pharmaceuticals (Troy, NY)
- …of management experience and a minimum of 2 years' experience in an FDA or similarly regulated environment or equivalent combination of education and experience. + ... more
- University of Utah (Salt Lake City, UT)
- …and international research consortia meetings. 6. Prepares, submits, and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research ... more
- Abbott (San Diego, CA)
- …requirements and other verification and validation tasks. + Ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate ... more
- Abbott (Austin, TX)
- …design controls and regulations for medical device development, (ISO134851, ISO13485, FDA ). + Strong technical experience in mechanical or chemical engineering with ... more
- Fairview Health Services (Minneapolis, MN)
- …diversion investigations and interactions with agencies such as the DEA and FDA . In addition to delivering strategic legal advice, this role will collaborate ... more
- Colgate-Palmolive (Sanford, ME)
- …of plant Documentation system (This includes all documents vital to an FDA inspection- SOP's, Management of Change, Notices of Deviation, Batch Records, Non ... more
- Integra LifeSciences (Plainsboro, NJ)
- …functional tests to ensure products meet regulatory requirements (such as FDA or ISO standards). Documentation and Reporting: They maintain detailed records ... more
- Bayer (Indianola, PA)
- …to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls. You will be involved in all aspects of the product ... more
- Medtronic (Fridley, MN)
- …Preventive Actions (CAPA) and Field Corrective Actions (FCA) processes, and Quality System Regulation FDA 21 CFR Part 820 and ISO 13485. Work on Complaints Mgmt. and ... more