- Edwards Lifesciences (Chicago, IL)
- …+ Collaborate with Quality, Regulatory, and Compliance teams to meet industry standards ( FDA , IEC, NIST) + Design, document or improve key processes for the service ... + Secure Software Development Life Cycle (SSLDC) experience + Knowledge of FDA guidelines + Writing testable cybersecurity requirements + Risk management lifecycle… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …standards. + Ensure adherence to US regulatory and industry standards including FDA promotional guidelines, PhRMA Code, and OIG compliance requirements. + Provide ... roles within the pharmaceutical or biotech industry. + Deep understanding of US FDA regulations, PhRMA Code, Sunshine Act, and other applicable laws and guidance. +… more
- Price Chopper (Schenectady, NY)
- …products are manufactured in compliance with food safety, GMP, HACCP, USDA, FDA , and corporate policies. + Maintain on-time completion of production schedules, ... with all corporate, federal, state, and local sanitation and safety guidelines (OSHA, FDA , USDA, EPA). + Engage in daily Redzone huddles and ensure team alignment… more
- Gilead Sciences, Inc. (El Segundo, CA)
- …teams + Create, revise, and approve LIMS system SOPs and reports per GMP, FDA , EU, Global, and ICH guidelines + Triage and evaluate site change requests, assess ... 5+ years of experience with SQL **Preferred Qualifications** + Strong understanding of FDA , ISO 13485, Medical Device Directive + Prior experience managing a team +… more
- J&J Family of Companies (Santa Clara, CA)
- …requirements, and supporting the Regulatory Affairs team to ensure compliance with FDA , EU MDR, and other relevant regulations. + Collaborate with Johnson & ... operations, and post-market surveillance is required. + Successful history leading FDA inspections, ISO certification audits, and MDSAP assessments, with a strong… more
- Terumo Medical Corporation (Somerset, NJ)
- …labeling requirements across US and international markets and ensures compliance with FDA , Terumo, and global regulatory standards. The Senior Labeling Specialist II ... + Ensure full compliance with US Food and Drug Administration ( FDA ) regulations, international regulatory requirements, company policies, operating procedures, and… more
- Dignity Health (Phoenix, AZ)
- …of human research policies, regulations, procedures, and standards according to FDA , ICH/GCP guidelines is required. This position interacts with a variety ... + Ensure the trial is conducted according to the protocol, ICH/GCP and FDA guidelines. + Administer study treatment interventions. + Collect specimens (blood, urine,… more
- North Coast Seafoods (Boston, MA)
- …of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer ... the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit… more
- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project + Manages all aspects ... and market plans + Assists in the writing of regulatory applications to the FDA and other regulatory bodies + Partners with the operations department to setup… more
- Cedars-Sinai (Los Angeles, CA)
- …and patient research billing. This role will comply with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and patient ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research practices using Good… more
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