Job Title: Regulatory Specialist

Job Description

The Regulatory Specialist is responsible for the implementation and oversight of compliance and operational efficiencies within the Quality and Regulatory Department. This position reports to the VP of Quality & Regulatory Affairs and is classified as exempt.

Responsibilities

• Prepare regulatory documents or submissions for new products being developed and changes to current products.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Interpret regulatory rules or rule changes and ensure that they are communicated through policies and procedures.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Determine the types of regulatory submissions or internal documentation that are required for proposed device changes 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.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Perform additional duties as assigned by supervisory or management personnel.

Essential Skills

• Bachelor’s degree in the sciences or a related field.
• At least 2 years of previous work experience in a similar regulatory position.
• Proficient in Microsoft Word, Excel, and Outlook.
• Knowledge of Microsoft Access preferred.
• Knowledge of Internet Explorer, Chrome, or Firefox.
• Willingness and ability to learn other software programs as needed.
• Knowledge of regulatory requirements for Class II devices.
• Knowledge of FDA Quality System Regulations (cGMP) and International Standards (ISO) pertaining to medical devices, including 21 CFR Part 820.
• Knowledge of basic lab equipment and analytical instrumentation.
• Effective communication skills to convey information effectively.
• Active listening skills to understand points being made, ask questions as appropriate, and not interrupt at inappropriate times.
• Complex problem-solving skills to identify issues, review related information, develop and evaluate options, and implement solutions.
• Judgment and decision-making skills to consider relative risks and benefits of potential actions.
• Systems evaluation skills to identify measures or indicators of system performance and the actions needed to improve or correct performance.

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 Mar 18, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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

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.

Salary : $38 - $55