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.

Requirements

• 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.

Skills

• 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.

Pay

The pay range for this position is $40.87 - $40.87/hr.

Benefits

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)