Regulatory Affairs Specialist

TEKsystems
$40.57 - $45.53 / hr
life insurance, sick time, 401(k), retirement plan
United States, Texas, Fort Worth
Jan 11, 2025
Description * Compile and maintain regulatory documentation databases or systems. * Coordinate efforts associated with the preparation of regulatory documents or submissions for medical devices (US, EU and Canada submissions). Communicate with internal stakeholders 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 corporate 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. Conduct regulatory impact assessment for post approval changes and support preparation of necessary submission documentation * Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. Pay and Benefits The pay range for this position is $40.57 - $45.53 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 Fort Worth,TX. Application Deadline This position will be accepting applications until Jan 25, 2025. About TEKsystems: We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.