Senior Regulatory Specialist

Company: Eurofins USA
Location: Davis
Posted on: November 12, 2021

Job Description:

Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2020, Eurofins generated total revenues of EUR --- 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description The Senior Regulatory Specialist is responsible for the implementation and oversight of Gold Standard Diagnostics' Regulatory System, to improve compliance and operational efficiencies. Essential Duties & Responsibilities

• 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. Provide review and direction to Regulatory Specialist.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Advise project teams and regulatory specialist 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 Education/Experience

• Must have a bachelor's degree in the sciences or related field.
• At least 5 years previous work experience in a similar regulatory position required. Computer Skills
  • Proficient in Microsoft Word, Excel, and Outlook.
  • Knowledge of Microsoft Access preferred.
  • Internet Explorer, Chrome, or Firefox.
  • Must be willing and able to learn other software programs as needed. Knowledge, Skills, and Other Abilities
  • Knowledge of Regulatory requirements for Class II devices.
  • Knowledge of FDA Quality Systems 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.
  • Effective communication - Ability to talk to others to convey information effectively.
  • Active listening - 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.
  • Complex Problem Solving - Ability to identify complex problems and review related information to develop and evaluate options and implement solutions.
  • Judgment and Decision Making - Ability to consider the relative risks and benefits of potential actions to choose the most appropriate one.
  • Systems Evaluation - 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.
  • Must be able and willing to adhere to corporation personnel policies and practices, including attendance and punctuality requirements. Additional Information All your information will be kept confidential according to EEO guidelines. Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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