Job Title: Regulatory Affairs Specialist with QA Experience

Looking for someone with at least 2 years of Regulatory and QA experience.

Job Description

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist with Quality Assurance (QA) experience to join our growing team. This role will be pivotal in ensuring the company's diagnostic products meet global regulatory standards and compliance requirements, while maintaining our commitment to quality.

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.
• Work closely 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.
• Collaborate with cross-functional teams to resolve any quality issues that may arise during product development or post-market activities.
• 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 compliance.

Essential Skills

• 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.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.
• Excellent attention to detail and strong problem-solving skills.

Additional Skills & Qualifications

• Knowledge of basic lab equipment and analytical instrumentation.
• Strong technical writing skills.
• Diverse communication skills.
• Leadership experience.
• Internal audit experience.
• Knowledge of FDA Quality System Regulations (cGMP) and International Standards (ISO) pertaining to medical devices, 21 CFR Part 820.

Work Environment

We are a global leader in diagnostic test kits and instruments for industries including food, feed, environmental, biopharma, animal health, and clinical sectors. Our cutting-edge R&D, manufacturing, and customer service teams deliver innovative, high-quality solutions designed to meet the needs of laboratories worldwide. The work environment is fast-paced and dynamic, requiring adherence to corporate personnel policies and practices, including attendance and punctuality requirements.

Pay and Benefits

The pay range for this position is $32.00 - $38.00/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 Feb 21, 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 : $32 - $38