• Regulatory Affairs Specialist

    Actalent (Davis, CA)


    Job Title: Regulatory Affairs Specialist

     

    Looking for a candidate that has at least 2-5 years of regulatory experience within Medical Device Class II. MUST HAVE: Regulatory experience, Experience with international registrations, ISO 13485 knowledge

    Responsibilities:

    + Oversee the regulatory affairs process for new and existing diagnostic products, ensuring compliance with FDA and other global regulations.

    + Prepare and submit regulatory documents, including product registrations and technical files.

    + Collaborate with R&D and manufacturing teams to ensure product quality aligns with regulatory requirements.

    + Perform regulatory assessments to ensure product development meets all applicable guidelines.

    + Monitor and interpret regulatory changes and provide guidance to the internal team on necessary actions.

    + Support the preparation for audits and inspections related to regulatory and quality systems.

    + Assist in the preparation and review of product labeling, packaging, and promotional materials for regulatory compliance1.

    Qualifications:

    + Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, or related field).

    + Minimum of 3 years of experience in Regulatory Affairs and Quality Assurance within the diagnostic or medical device industry.

    + In-depth knowledge of FDA regulations (21 CFR) and other global regulatory requirements.

    + Experience with product registrations, technical files, and regulatory submissions.

    + Strong understanding of QA principles and experience in ensuring product quality throughout the lifecycle

    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 May 12, 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.