- Bayer (Berkeley, CA)
- …including a current understanding of USP/EP, cGMP regulations, ICH, and FDA Guidance Documents. Provide support during internal/external audits; * Ability to ... management, Risk Management, etc.); + Expertise in cGMP and regulatory requirements ( FDA , EMA, ICH, etc.); + Expertise in performing investigative work; + Knowledge… more
- Valent BioSciences (Libertyville, IL)
- …of programs related to internal and external audits, including those by the FDA , EMA, ISO registrars, and other regulatory bodies. + Collaborate with R&D, ... and biosafety programs. Skills and Competencies + Deep understanding of FDA , EMA, ISO 9001/14001/45001, and other global regulatory frameworks. + Strong… more
- System One (Monmouth Junction, NJ)
- …involves operating packaging equipment, ensuring compliance with batch records and FDA guidelines, and maintaining accurate documentation. The position offers a ... and maintain batch records and other required documentation. + Follow SOPs, cGMPs, FDA standards, and safety procedures at all times. + Collaborate with production… more
- Abbott (Tipp City, OH)
- …nutritional products. + This position is accountable for complying with applicable FDA , GMP, OSHA and Abbott regulations, policies, procedures or guidelines You'll ... be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures. **Shift** This is a **night shift position (6:30pm -… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …and presentations. Conduct verification and validation testing in accordance with FDA and ISO standards. Support regulatory submissions by documenting algorithm ... delivery systems, mechanical ventilators and anesthesia delivery systems. Experience with FDA design controls and IEC software lifecycle processes. Knowledge of… more
- AssistRx (Orlando, FL)
- …Market & Pipeline Intelligence + Conduct ongoing research on the FDA drug pipeline, clinical trial activity, company announcements, and market movements. ... strongly preferred. + Working knowledge of the drug development lifecycle, FDA approval pathways, and clinical trial registries. + Experience using 6sense,… more
- Integra LifeSciences (Princeton, NJ)
- …+ Participate in design and change control activities. + Participate in FDA inspections, ISO Certification and Surveillance audits and Internal audits. + Collaborate ... in a regulated environment. Skills/Knowledge: + Work experience in an FDA /ISO regulated environment preferred. + Excellent interpersonal communication skills -… more
- 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