Document Specialist

Document Specialist We are seeking a detail-oriented Document Specialist to support document control, quality management, and regulatory compliance activities within a medical device environment. The ideal candidate will have hands-on experience with Windchill document management systems and an understanding of the European Medical Device Regulation (EU MDR 2017/745). This is a remote position requiring excellent organizational skills, accuracy, and the ability to collaborate effectively across cross-functional teams. Responsibilities Manage document control activities within the Windchill PLM/document management system. Create, review, route, track, and maintain controlled documents, including procedures, work instructions, specifications, technical files, and quality records. Ensure documentation complies with company quality standards, regulatory requirements, and document control procedures. Support EU MDR compliance initiatives by maintaining regulatory documentation and technical documentation records. Facilitate document review and approval workflows and ensure timely completion of change requests. Maintain revision histories, document metadata, and controlled distribution records. Collaborate with Regulatory Affairs, Quality Assurance, Engineering, Clinical, and Operations teams to ensure documentation accuracy and completeness. Essential Skills Associate's or Bachelor's degree in Business, Life Sciences, Engineering, Quality, Regulatory Affairs, or a related field, or equivalent experience. 3+ years of experience in document control, quality systems, or regulatory document management. Experience using Windchill for document management and change control processes. Working knowledge of medical device documentation practices. Experience managing controlled documents within a regulated environment. Strong attention to detail and organizational skills. Proficiency with Microsoft Office applications, including Word, Excel, and Outlook. Excellent written and verbal communication skills. Additional Skills & Qualifications Experience working in the medical device industry. Familiarity with ISO quality management systems. Experience supporting technical documentation, design history files (DHF), device master records (DMR), or technical files. Knowledge of change control, CAPA, and quality management processes. Work Environment This is a remote position with standard business hours and flexibility to support global teams as needed. Occasional travel (up to 10%) may be required for team meetings or training. Job Type & Location This is a Contract position based out of Centennial, CO. Pay and Benefits The pay range for this position is $40.87 - $40.87/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 Jul 30, 2026. 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. 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 View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.