Senior Document Control Specialist – Regulated Life Sciences

Accuray; Madison (WI); Presencial; USD 60.000 - 90.000; Jornada completa

Descripción de la vacante

Accuray is seeking a document-control specialist to administer the controlled-document lifecycle, review submissions, and ensure alignment with quality-system requirements. You will maintain metadata, revision history, and access in electronic systems, supporting audits and training activities in a regulated medical-device environment.

The role involves preparing and distributing records, ensuring data integrity, and collaborating with global teams to uphold Good Documentation Practices.

Formación

• Associate degree or equivalent combination of education and relevant experience.
• Two years of experience in document control, change control, records management, or a related regulated field.
• Familiarity with Good Documentation Practices and data-integrity principles.
• Experience with ISO 13485, FDA QMS requirements, EU MDR, MDSAP.
• Proficiency with Microsoft 365 apps (Word, Excel, Outlook, Teams).
• Ability to interpret procedures and maintain confidentiality across global teams.

Responsabilidades

• Administers controlled-document lifecycle activities, including creation, review, approval, issuance, revision, and archival.
• Reviews submissions for completeness, accuracy, approvals, and training impact; ensures regulatory compliance.
• Maintains document metadata, revision history, access permissions, and audit trails in enterprise systems.
• Sets up and maintains users, roles, and access in MasterControl and related systems.
• Monitors queues, aging, and cycle times; follows up on overdue records.
• Develops and maintains documents, templates, and training materials; provides guidance to authors and reviewers.
• Supports Change Review Boards with agendas, minutes, and action items; records decisions.
• Coordinates translation of documents and maintains version control across languages.
• Participates in audits and regulatory inspections by providing traceability evidence.
• Supports system implementations, upgrades, and data cleanups affecting document control.

Conocimientos

Document control

Change control

Quality systems

Good Documentation Practices

ISO 13485 familiarity

FDA QMS familiarity

Microsoft 365

Educación

Associate degree or equivalent

Herramientas

MasterControl

Electronic document-management systems

Descripción del empleo

Accuray is seeking a document-control specialist to administer the controlled-document lifecycle, review submissions, and ensure alignment with quality-system requirements. You will maintain metadata, revision history, and access in electronic systems, supporting audits and training activities in a regulated medical-device environment.

The role involves preparing and distributing records, ensuring data integrity, and collaborating with global teams to uphold Good Documentation Practices.