What are the responsibilities and job description for the Senior Consultant Regulatory Affairs position at Actalent?
Actalent is hiring for a Remote Sr Consultant Regulatory Affairs in Deerfield, IL!
Job Description
Under general supervision, the Senior Consultant Regulatory Affairs is responsible for coordinating and preparing documents/packages for regulatory submissions. The role involves reviewing and evaluating technical and scientific data and reports necessary to support the company's products.
Responsibilities
- Coordinate and prepare documents/packages for regulatory submissions.
- Review and evaluate technical and scientific data and reports required for submissions.
- Track the status and progress of regulatory documentation.
- Review, edit, and proofread regulatory documentation.
- Assist in the preparation and review of labeling SOPs and other departmental documents.
- Compile regulatory documents for submission under supervision.
- Participate actively as a team member of project teams as required.
- Compile and prepare responses to regulatory authorities' questions.
- Maintain regulatory files in a format consistent with requirements.
- Maintain awareness of regulatory requirements.
- May manage a specific product portfolio within the region.
Essential Skills
- Experience in Medical Device Regulatory Affairs.
- Familiarity with regulatory submission processes, particularly EU MDR.
- Strong knowledge of FDA regulations and compliance.
- Proficiency in handling regulatory documents.
Additional Skills & Qualifications
- Bachelor's Degree (BS) required.
- 2-4 years of experience in Regulatory Affairs.
- Experience with EU MDR is essential.
Work Environment
This position is 100% remote, offering flexibility and the ability to work from any location.
Job Type & Location
This is a Contract position based out of Deerfield, IL.
Pay and Benefits
The pay range for this position is $45.00 - $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 remote position.
Application Deadline
This position is anticipated to close on Dec 5, 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.
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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $45 - $55