Job Description

Regulatory Affairs Specialist IVD/Class II Medical Device Description The Regulatory Specialist is responsible for the implementation and oversight of Regulatory System, to improve compliance and operational efficiencies. Essential Duties & Responsibilities 1. Preparation of regulatory documents or submissions for new products being developed and changes to current products 2. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review 3. Coordinate, prepare, or review regulatory submissions for domestic or international projects 4. Interpret regulatory rules or rule changes and ensure that they are communicated through policies and procedures 5. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation 6. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies 7. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. 8. Determine the types of regulatory submissions or internal documentation that are required for proposed device changes or labeling changes 9. Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance 10. Prepare or coordinate the preparation of additional information or responses as requested by regulatory agencies 11. Prepare or maintain technical files as necessary to obtain and sustain product approval 12. Perform additional duties as assigned by supervisory or management personnel 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 - Proficient in Microsoft Word, Excel, and Outlook + Experience with Regulatory requirements for Class II devices + Experience with 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 Pay and Benefits The pay range for this position is $38.00 - $55.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Davis,CA. Application Deadline This position is anticipated to close on Jun 24, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Job Tags

Temporary work, Work experience placement,

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