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Regulatory/Quality Compliance Specialist

Responsibilities

• Manage product data on internal Regulatory Affairs and external FDA databases.
• Ensure compliance with federal and international regulations, standards, and internal policies.
• Prepare, verify, and maintain technical files for FDA submissions and other required activities.
• Support the regulatory implications of the product profile.
• Collaborate with Regulatory CMC, Publishing, and Labeling groups for compliance with annual reports and regulatory submissions.
• Utilize RegTrack system for data entry and compliance.

Essential Skills

• BS Degree Preferred, AS Degree or HS Diploma may be considered
• 1-3 years of Regulatory Affairs Experience in FDA Pharma or Device (Quality Assurance experience may be considered)
• Attention to Detail
• Strong Communication Skills
• Strong Computer/Quality Systems and Regulatory Systems Experience (RegTrack)

Work Environment

Hybrid work environment with 3 days on-site and 2 days work from home; Wednesday is mandatory on-site.

Pay and Benefits

The pay range for this position is $30.00 - $30.00

Requirements

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 hybrid position in Lake Zurich,IL.

Application Deadline

This position will be accepting applications until Jan 23, 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.