- Stryker (Mahwah, NJ)
- …compassionate use pathways. + Direct interactions with health authorities (eg, FDA , EU Notified Bodies) and guide internal teams through regulatory communications. ... Science, or related field. + Minimum **10** years of experience in an FDA -regulated industry. + Minimum **5** years of experience in a supervisory or people… more
- System One (Monmouth Junction, NJ)
- …root cause analysis to ensure compliance with SOPs, cGMPs, and FDA requirements. Responsibilities + Perform maintenance and troubleshooting on packaging equipment ... and physical + High school/GED + Proficient in manufacturing procedures, FDA regulations, cGMPs, SOPs + Ability to read/interpreting safety, maintenance, and… more
- Curia (Springfield, MO)
- …compilation, systems and controls to ensure inspection-ready quality systems (ISO, FDA , QP, EMEA) for domestic and international inspections and registrations + ... QA experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA -regulated industry Preferred + Experience working with third-party contract… more
- Curia (Springfield, MO)
- …to effectively utilize team resources + Expert in cGMP, USP, EP and FDA regulations + Technical competence including the understanding of theory and interpretation ... other analytical techniques and analytical equipment + Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); Physical requirements The physical… more
- Norstella (Lincoln, NE)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... concepts + Experience in using research tools and databases (eg, ClinicalTrials.gov, EMA, FDA , SEC filings) + High proficiency in MS Office Suite (Excel, Word,… more
- WuXi AppTec (Middletown, DE)
- …operation and maintenance experience in a Life Sciences/Pharmaceuticals/Biotechnology or FDA -regulated environment required + Strong knowledge of GMP, FDA ... , OSHA, and industry best practices in Utilities Equipment and systems operation and maintenance + Hands-on past experience with cleanrooms, HVAC systems, water purification, compressed air, electrical systems, pressure/temperature/flow instrumentation,… more
- GRAIL (Dover, DE)
- …author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team ... Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and international… more
- Compass Group, North America (Aurora, CO)
- …results-driven culture Compliance & Incident Response * Ensure adherence to OSHA, FDA , USDA, EPA and other regulations * Investigate incidents and develop Corrective ... credentials preferred. * 5-10 years experience in manufacturing preferred focus on FDA regulated production * Strong analytical and investigative skills * Knowledge… more
- Globus Medical, Inc. (Eagleville, PA)
- …others + Monitors compliance within company policies and procedures (eg, compliance with FDA , ISO 13485, or other regulations). + Complies with all safety and health ... in a supervisory capacity + Demonstrated knowledge of ISO and quality systems as FDA and OSHA requirements, as a plus + Experience analyzing and presenting detailed… more
- Globus Medical, Inc. (Eagleville, PA)
- …requirements + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... ability to understand and comply with applicable Food & Drug Administration ( FDA ) regulations and Company operating procedures, processes, policies, and rules is… more