• Regulatory Affairs Specialist

    Actalent (Davis, CA)


    Regulatory Specialist – Onsite | Davis, CA

     

    Local Candidates Only – This is a full-time onsite role in Davis, CA (Monday–Friday)

     

    Department: Quality and Regulatory

    Position Summary

    A growing life sciences organization is seeking a detail-oriented and proactive Regulatory Specialist to support and enhance its regulatory systems and ensure compliance with domestic and international standards. This role is critical in preparing regulatory submissions, maintaining documentation, and supporting product development from a compliance perspective. The ideal candidate will be local to the Davis area and available to work onsite five days a week.

    Key Responsibilities

    + Prepare regulatory documents and submissions for new and existing products.

    + Communicate with regulatory agencies regarding submission strategies, compliance requirements, and follow-ups.

    + Coordinate and review domestic and international regulatory submissions.

    + Interpret and implement regulatory changes through updated policies and procedures.

    + Review technical data and reports for accuracy and regulatory compliance.

    + Evaluate product labeling, promotional materials, and test methods for regulatory adherence.

    + Advise cross-functional teams on regulatory requirements, including labeling and clinical compliance.

    + Determine appropriate documentation for device or labeling changes.

    + Identify and interpret relevant regulatory guidance and standards.

    + Respond to agency requests and maintain technical files for product approvals.

    + Support internal audits and continuous improvement initiatives.

    + Perform additional duties as assigned.

    Qualifications

    Education & Experience

     

    + Bachelor’s degree in a scientific discipline or related field required.

    + Minimum of 2 years of experience in a regulatory affairs role, preferably in medical devices.

     

    Technical Skills

     

    + Proficient in Microsoft Word, Excel, Outlook; familiarity with Access preferred.

    + Comfortable using web browsers and learning new software tools.

     

    Regulatory Knowledge

     

    + Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971.

    + Experience with Class II medical devices and regulatory documentation.

    + Understanding of lab equipment and analytical instrumentation.

    Core Competencies

    + Strong written and verbal communication skills.

    + Active listening and collaborative problem-solving.

    + Ability to manage complex tasks and make sound decisions.

    + Experience with internal audits and regulatory inspections.

    + High attention to detail and organizational skills.

    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 25, 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 [email protected] (%[email protected]) for other accommodation options.