- Grifols Shared Services North America, Inc (San Carlos, CA)
- …organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of ... global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet… more
- Danaher Corporation (West Sacramento, CA)
- …+ Manufacturing/Production environment, medical device manufacturing and/or other FDA -regulated industry and certifications in Electrical, Mechanical, Welding, or ... other relevant job skills is preferred. + Using a computer to send and receive e-mails, open and update work orders, enter timesheet information, and ability to learn and utilize computerized work order and PM systems (CMMS). + Welding and metal parts… more
- Imperative Care (Campbell, CA)
- …Experience working under quality systems designed to meet governmental regulations such as FDA , GMPs, QSR, ISO 13485/9001, and the MDD. + Experience leading a ... technical cross-functional team through all phases of product development. Strong understanding of braiding, laminating, coiling, and laser cutting design and process constraints. + Ability to be self-directed with minimal direction and supervision and take… more
- ThermoFisher Scientific (Fremont, CA)
- …and regulatory standards **Knowledge, Skills, Abilities** + Knowledge of manufacturing techniques, FDA , GMP, and ISO 13485 compliance + Proven ability to achieve ... results, communicate effectively, and make sound decisions in uncertain conditions **Physical Requirements / Work Environment** The physical work requirements typically include a combination of office and labwork. Must be able to lift up to 25 pounds.… more
- Lundbeck (Fresno, CA)
- …including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... **REQUIRED EDUCATION, EXPERIENCE and SKILLS:** + Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university + 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience +… more
- Sumitomo Pharma (Sacramento, CA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- Cedars-Sinai (CA)
- …of Health (NIH), Department of Defense (DOD), Food and Drug Administration ( FDA ) and the Institutional Review Board. Prepares and routes internal documents for ... signature and processing, works with PI's and ORA staff to submit all deliverables in a timely manner including: FFR's, No Cost Extensions, Carry Forward of Funds, executing subcontracts, etc. **Primary Duties & Responsibilities:** + Independently performs all… more
- Norstella (Sacramento, CA)
- …to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + Support client engagements by participating in scoping discussions ... and helping design custom RWD solutions that address key clinical, regulatory, and business questions. + And other duties as assigned. **Qualifications:** + Advanced degree (Master's or Doctorate) in Biostatistics, Epidemiology, Public Health, Pharmacy… more
- Abbott (Santa Clara, CA)
- …development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to achieve departmental and organizational ... objectives + Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory obstacles and emerging issues… more
- Stanford Health Care (Palo Alto, CA)
- …nursing to coordinate drug therapy. + Participates in audits from the sponsors, FDA , DEA, NIH and other regulatory agencies as needed. **Education Qualifications** + ... Bachelor's in Pharmacy from an accredited college or university. **Experience Qualifications** + Two (2) years of progressively responsible and directly related work experience. + One (1) year if completed a PGY1 residency. **Required Knowledge, Skills and… more