- Medtronic (Northridge, CA)
- …of ISO 10993 and global medical device regulations (eg, EU MDR, FDA , REACH, Prop 65). + Experience with biocompatibility assessments, toxicological risk evaluation, ... and material characterization. + Experience with analytical techniques (eg, LC, GC, MS) and drug compatibility testing. + Knowledge of design control, risk management, and design verification/validation processes. + Strong technical writing, data analysis, and… more
- Globus Medical, Inc. (San Diego, CA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This ... individual will work with spine surgeons and all other functions of the company to ensure high quality and on-time product introductions. **Essential Functions:** + Designing and developing instruments and implants using Pro/E software + Working with in-house… more
- Fujifilm (Santa Ana, CA)
- …years of inventory control/ cycle count experience. + Experience in ISO and FDA regulated businesses, and cGMP environment a plus. + Ability to perform arithmetic ... (eg, add, subtract, divide and multiply) routinely. + Knowledge of the metric system. + Operate sit-down and stand-up forklift. + Knowledge of cycle count process. + Knowledge of ERP systems and RF scan guns. + Knowledge of Good Manufacturing Practices (GMPs).… more
- Cardinal Health (Sacramento, CA)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). * Draft, ... negotiate and review a wide range of agreements, including complex matters relating to manufacturer supply agreements and co-marketing arrangements. * Advise and ensure that internal clients receive sound, practical and timely legal advice on a wide variety of… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …with software development lifecycle (SDLC) and validation tools. + Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks. + A strong technical ... and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups. + Technical expertise to define validation approaches and execution of… more
- ZOLL Medical Corporation (San Jose, CA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- Compass Group, North America (San Francisco, CA)
- …wellness related programs and initiatives and to ensure compliance with FDA nutrition labeling laws. **Key Responsibilities:** + Understands and executes Bon ... Appetit's food philosophy and wellness programs including Company wellness commitments and op-in wellness offerings. + Supports account in meeting nutrition related regulatory requirements including federal menu labeling laws, local and state requirements for… more
- Medtronic (Orange, CA)
- …in a manner that adheres to ethics & compliance guidelines and FDA requirements **Communication:** + Work with internal functions (marketing, customer service, ... finance, etc.) to meet targets (ie, Inventory management audits, customer service protocols, etc.) + Communicate market intelligence/competitor activity promptly, including potential sales leads, information regarding product pricing or account activity to… more
- Kelly Services (Thousand Oaks, CA)
- …up on acknowledgments + Support vendor onboarding and maintain compliance with ISO/ FDA procedures + Assist with RFPs, contract routing, and purchasing system updates ... (eg, iBuy, Ariba, Coupa) **What You Bring:** + 3+ years in purchasing, preferably in manufacturing or a regulated industry + Strong experience with SAP (required); Oracle or JD Edwards helpful + Comfortable managing high SKU volumes and multiple suppliers +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Agile delivery experience + Track record working in a fast paced, FDA regulated IT environment + Experience managing consultants and providing technical ... recommendations + Ability to work independently and manage multiple projects & priorities + Excellent written and verbal communication skills The salary range for this position is: Bay Area: $146,540.00 - $189,640.00. Raleigh: $126,565.00 - $163,790.00. Gilead… more