Senior Regulatory Specialist
Company: Eurofins USA
Posted on: November 12, 2021
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
- 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
- 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
- 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
- Effective communication - Ability to talk to others to convey
- 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
- Complex Problem Solving - Ability to identify complex problems
and review related information to develop and evaluate options and
- Judgment and Decision Making - Ability to consider the relative
risks and benefits of potential actions to choose the most
- 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
Keywords: Eurofins USA, Davis , Senior Regulatory Specialist, Other , Davis, California
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