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
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Davis, CA are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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
Ability and 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
This role is on-site at our facility in Davis, CA and cannot be done remotely.
Additional Salary Information: Pay is based on experience
Internal Number: REF11202C
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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics 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, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability an...d purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years