Senior Regulatory Specialist
Company: Eurofins USA
Posted on: November 15, 2021
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
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
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.
The Senior Regulatory Specialist is responsible for the
implementation and oversight of Gold Standard Diagnostics'
Regulatory System, to improve compliance and operational
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
Must have a bachelor's degree in the sciences or related field.
At least 5 years previous work experience in a similar regulatory
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
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
All your information will be kept confidential according to EEO
Eurofins is aM/F, Disabled, and Veteran Equal Employment
Opportunity and Affirmative Action employer.
Keywords: Eurofins USA, Davis , Senior Regulatory Specialist, Other , Davis, California
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