Regulatory Specialist at Gold Standard Diagnostics, LLC in Davis, California

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.




Job Description




Summary



The 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

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

Scope of Authority

Regulatory approval for DACF's, reports and submissions



Qualifications



To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



Education/Experience

• 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

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 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

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

Certificate and Licenses

• Must maintain a valid driver's license with a satisfactory driving record.

Reasoning Ability



Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to apply principles of logical or scientific thinking preferred.



Math Ability



Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to work with mathematical concepts such as probability and statistical inference preferred.



Language Ability



Must have the ability to perform all the following in English:

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, technical journals, or governmental regulations.


• Ability to write regulatory submissions, reports, business correspondence and procedure manuals


• Ability to effectively present information and respond to questions from groups of managers, regulatory agencies, and customers,


• Ability to effectively present information to top management


• Ability to respond to the most sensitive questions from regulatory agencies

Equipment

• Must be able to use basic office equipment such as computers, copiers, scanners, faxes, telephone systems, etc.

Physical Demands & Work Environment



The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


In this position, the employee will be required to work in a team environment where the noise level is usually moderate. While performing the duties of this job, the employee is regularly required to sit stand; walk; sit; use hands; talk; and hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stoop, kneel, or crouch. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, ability to adjust focus, and ability to see color.



Additional Information




Compensation:

• Salary: $80-$110K

Schedule:

• Monday-Friday 8:00am-5:00pm

What we offer:

• 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 USA In Vitro Diagnostics Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

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