Senior Document Control Specialist Regulated Life Sciences

Accuray Incorporated; Madison (WI); On-site; USD 60,000 - 80,000; Full time

Job summary

Accuray Incorporated is seeking a detail-oriented Document Control professional to manage lifecycle activities, review change-control submissions, and ensure alignment with QMS requirements in a regulated medical-device environment.

You will maintain metadata, user access, and audit evidence across MasterControl and related systems, while supporting internal and external audits and system validations. Collaboration with global teams is essential.

Qualifications

• Associate degree or an equivalent combination of education and relevant experience.
• At least two years of experience in document control, change control, records management, quality systems, or a related function in a regulated industry.
• Working knowledge of Good Documentation Practices, data-integrity principles, and controlled-document lifecycle requirements.
• Familiarity with ISO 13485, FDA Quality Management System requirements, EU MDR, MDSAP, and applicable electronic-record and electronic-signature requirements.
• Experience using electronic document-management, quality-management, training-management, or product-lifecycle management systems.
• Proficiency with Microsoft 365 applications, including Word, Excel, Outlook, and Teams.
• Ability to interpret and consistently apply procedures, work instructions, templates, and documentation standards.
• Attention to detail, sound judgment, problem-solving ability, and capacity to manage multiple priorities and deadlines in a fast-paced environment.
• Effective written and verbal communication skills and the ability to work collaboratively with global and cross-functional teams while maintaining confidentiality.
• Experience in the medical-device, pharmaceutical, biotechnology, or other regulated life-sciences industry.

Responsibilities

• Administers controlled-document lifecycle activities from creation to archival.
• Reviews change-control submissions for completeness and compliance.
• Ensures documents align with templates and QMS requirements.
• Maintains document metadata, revision history, and access controls.
• Sets up and maintains users and roles in MasterControl and related systems.
• Supports audits and regulatory inspections with traceability evidence.
• Participates in system implementations, upgrades, and validation activities.

Skills

Document control

Change control

Quality systems

Regulated industry

Microsoft 365

Written and verbal communication

Attention to detail

Multitasking

Cross-functional collaboration

Training and mentoring

Education

Associate degree or equivalent

Bachelor's degree preferred

Tools

MasterControl

Agile

Oracle

SAP

Job description

Accuray Incorporated is seeking a detail-oriented Document Control professional to manage lifecycle activities, review change-control submissions, and ensure alignment with QMS requirements in a regulated medical-device environment.

You will maintain metadata, user access, and audit evidence across MasterControl and related systems, while supporting internal and external audits and system validations. Collaboration with global teams is essential.