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Regulatory Specialist

Company: Eurofins USA
Location: Davis
Posted on: November 23, 2021

Job Description:

Company Description Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA. Group's key figures (as of March 2020) are approx. 5.4billion Euros turnover, over 800 laboratories across 50countries and about 50,000 staff. Job Description

  • Preparation of regulatory documents or submissions for new products being developed and changes to current products
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects
  • Interpret regulatory rules or rule changes and ensure that they are communicated through policies and procedures
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Determine the types of regulatory submissions or internal documentation that are required for proposed device changes or labeling changes
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
  • Prepare or coordinate the preparation of additional information or responses as requested by regulatory agencies
  • Prepare or maintain technical files as necessary to obtain and sustain product approval
  • Perform additional duties as assigned by supervisory or management personnel Qualifications Qualifications The ideal candidate would possess:
    • Knowledge of Regulatory requirements for Class II devices
    • Knowledge of FDA Quality System Regulations (cGMP) and International Standards (ISO) pertaining to medical devices, 21 CFR Part 820, ISO 13485, ISO 14971
    • Knowledge of basic lab equipment and analytical instrumentation required
    • Ability to talk to others to convey information effectively
    • Ability to give full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times
    • Ability to identify complex problems and review related information to develop and evaluate options and implement solutions
    • Ability to consider the relative risks and benefits of potential actions to choose the most appropriate one
    • Ability to Identify measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
    • Internal audit experience
    • Abilityand willingness to adhere to corporation personnel policies and practices, including attendance and punctuality requirements Basic Minimum Qualifications:
      • Must have a bachelor's degree in the sciences or related field
      • At least 2 years previous work experience in a similar regulatory position required
      • Proficient in Microsoft Word, Excel, and Outlook
      • Knowledge of Microsoft Access preferred
      • Proficient with Internet Explorer, Chrome, or Firefox
      • Must maintain a valid driver's license with a satisfactory driving record Additional Information We offer you: --- A position with responsibility within a dynamic company --- Working in an innovative and international environment together with a dynamic team. --- Professional and personal development is supported. --- Sustainable and meaningful approach in everything we do. --- A salary, depending on your experience, based on market practice. --- Competitive bonus and stock option plan. Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Keywords: Eurofins USA, Davis , Regulatory Specialist, Other , Davis, California

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