What are the responsibilities and job description for the Regulatory Affairs Specialist - Exempt position at Actalent?
Job Title: Remote Regulatory Affairs Specialist
Job Description
We are seeking a detail-oriented Regulatory Affairs Specialist to coordinate and prepare document packages for regulatory submissions across various company departments. This role involves leading or compiling materials required for submissions, license renewals, and annual registrations, while recommending changes to labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance. The specialist will monitor and improve tracking systems, keep abreast of regulatory procedures and changes, and may interact directly with regulatory agencies. You will recommend strategies for the earliest possible approvals of clinical trial applications.
Responsibilities
- Direct and perform coordination and preparation of document packages for regulatory submissions from all areas of the company.
- Lead or compile all materials required in submissions, license renewals, and annual registrations.
- Recommend changes for labeling, manufacturing, marketing, and clinical protocol to ensure regulatory compliance.
- Monitor and improve tracking/control systems.
- Stay updated with regulatory procedures and changes.
- Direct interaction with regulatory agencies on defined matters.
- Recommend strategies for the earliest possible approvals of clinical trial applications.
- Deliver and manage projects assigned, working with other stakeholders to achieve desired results.
- Act as a mentor to colleagues or direct the work of lower-level professionals.
Essential Skills
- Practical knowledge and demonstrated competence within the job area.
- University Degree with a minimum of 2 years of relevant experience or an advanced degree with 0 years of experience.
- 1-3 years of experience in the Medical Device industry.
- Familiarity with FDA 21 CFR Part 820 and EU 217/745 (EU MDR).
- Knowledge of Microsoft Office Applications (Word, Excel, Access, PowerPoint) and Windows OS.
Additional Skills & Qualifications
- Bachelor’s degree required.
- 3-5 years of experience required.
- Experience with EU MDR Technical Documents to support submissions and Notices of Change.
- Understanding of Design Controls and Change Management.
- Experience with interaction with Notified Bodies and Competent Authorities.
Work Environment
This is a remote position requiring 40 hours of work per week, with quarterly team meetings that may necessitate on-site presence. The work environment is professional, with opportunities for collaboration across teams. Employees should be prepared to communicate frequently with internal contacts to share information and support decision-making.
Job Type & Location
This is a Contract position based out of Moorpark, CA.
Pay and Benefits
The pay range for this position is $65.00 - $65.00/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 Nov 7, 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 : $65