- Butterball (Yellville, AR)
- …practices are completed and documented appropriately. Ensures compliance with all FDA and regulatory requirements, including necessary documentation.. Partners ... more
- TE Connectivity (Wilsonville, OR)
- …parties regarding the QMS (eg, customer, assessor, FDA & other regulatory entities); leading quality improvement initiatives in support of customer and ... more
- Unither Pharmaceuticals (Rochester, NY)
- …*Areas of expertise should include most, if not all of the following: GMP, FDA , regulatory affairs and compliance, quality assurance and controls, ... more
- Stryker (Kalamazoo, MI)
- …(ie Certified Lead Auditor) + 4+ years medical device or FDA regulatory industry experience + 2+ years Quality Audit experience (internal, external, and/or ... more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …laboratory audit ready status efforts in understanding FDA , Takeda, and other regulatory and quality requirements. Maintain a high level of expertise in ... more
- Interstate Blood Bank (Vista, CA)
- …a significant size manufacturing operation. **KNOWLEDGE, SKILLS, ABILITIES** Thorough knowledge of FDA and international regulatory , quality and cGMP ... more
- MTF (Edison, NJ)
- …in scientific discipline (eg Biology, Chemistry, etc.) **Experience:** 0-3 years of quality assurance or FDA regulatory proficiency required **Specific ... more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …laboratory audit ready status efforts in understanding FDA , Takeda, and other regulatory and quality requirements. Maintain a high level of expertise in ... more
- Jabil (Mebane, NC)
- …of SOPS, cGMP, EN ISO 13485, EN ISO 9001, 21 CFR 820/201/211, and FDA / Regulatory requirements of the Quality System. Takes personal accountability for ... more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …audits and external audits conducted by the FDA and other regulatory agency representatives. Support Quality Management Systems by increasing regulatory ... more
- The Boeing Company (North Charleston, SC)
- … FDA Delegate, mechanic or quality technician accomplishing FDA -sensitive installations/inspections + Experience working with a regulatory agency + ... more
- Boehringer Ingelheim (Ridgefield, CT)
- …reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory relevant ... more
- Cambrex High Point (Charles City, IA)
- …Start a career where You Matter by applying today! Job Overview The Head of Quality and Regulatory position at the Charles City site is responsible for site ... more
- Fujifilm (College Station, TX)
- **Position Overview** **Summary:** The Quality Assurance Regulatory Affairs Supervisor is responsible for supporting the electronic publishing of regulatory ... more
- Astellas Pharma (Northbrook, IL)
- …on Corporate Integrity Agreements. + Supports cross-functional discussions of Significant Quality Issues (SQIs), particularly with respect to FDA reporting ... more
- Actalent (Morristown, NJ)
- … FDA (OGD/CDER) e-submission requirements. + Experience with CMC regulatory requirements. Additional Skills & Qualifications + Experience in generic ... more
- Houston Methodist (Houston, TX)
- …study team and sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different ... more
- Fresenius Medical Center (Waltham, MA)
- …term schedule planning for the Product Team. + Authoring, reviewing and coordinating quality submissions to regulatory agencies for viable product strategies and ... more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … affairs, with a focus on medical device systems + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485, IEC 62304) + Solid understanding ... more
