Regulatory Affairs Specialist

Job Title:

Regulatory Affairs Specialist Job Description The Regulatory Affairs Specialist is responsible for the implementation and oversight of the regulatory system, aimed at improving compliance and operational efficiencies. This role is situated within the Quality and Regulatory Department and reports to the VP of Quality & Regulatory Affairs. Responsibilities Prepare regulatory documents or submissions for new products and changes to current products. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and submissions under review. Coordinate, prepare, or review regulatory submissions for both domestic and international projects. Interpret regulatory rules or rule changes and ensure they are communicated through policies and procedures. Provide technical review of data or reports for regulatory submissions to ensure scientific rigor, accuracy, and clarity. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations. Advise project teams on premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. Determine the types of regulatory submissions or internal documentation required for proposed device 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. Maintain technical files necessary to obtain and sustain product approval. Perform additional duties as assigned by supervisory or management personnel. Essential Skills Bachelor's degree in sciences or related field. At least 2 years of previous work experience in a similar regulatory position. Proficiency in Microsoft Word, Excel, and Outlook. Knowledge of FDA Quality System Regulations (cGMP) and International Standards (ISO) pertaining to medical devices. Effective communication and active listening skills. Complex problem-solving and decision-making abilities. Systems evaluation capabilities. Additional Skills & Qualifications Knowledge of basic lab equipment and analytical instrumentation. Internal audit experience. Must maintain a valid driver's license with a satisfactory driving record. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to calculate figures and amounts such as discounts, interest, commissions, and percentages. Work Environment The role is based onsite, Monday through Friday, during the day shift, with flexibility as long as work is completed. The team environment is collaborative, with a moderate noise level. Physical demands include sitting, standing, walking, and occasionally lifting up to 10 pounds. The workplace promotes a great culture and team environment. Job Type & Location This is a Contract to Hire position based out of Davis, CA. 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 Apr 29, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.