Regulatory Affairs Specialist

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 May 29, 2026.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.