Regulatory Document Controller — EDMS Expert

Neuronetics; Malvern (Chester County); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan with company contribution

Paid time off

Flexible PTO

Job summary

Neuronetics seeks a skilled Document Control Specialist to manage QMS documentation and training within a regulated medical device setting. You will oversee SOPs, records, and training in the EDMS, ensuring alignment with FDA, ISO, QMSR, and MDSAP requirements while collaborating with multiple departments.

The role requires precision, strong writing, cross-functional coordination, and the ability to drive change control and training programs across the organization.

Qualifications

• Associate degree required with 5+ years in a regulated industry (medical devices preferred).
• Demonstrated expertise in EDMS systems and document control processes.
• Strong technical writing, proofreading, and ISO 13485 knowledge.
• Experience supporting internal audits and external inspections.

Responsibilities

• Create, review, revise, and archive SOPs, work instructions, and records.
• Maintain revision history and master control for controlled documents.
• Provide EDMS training and guidance to users across departments.
• Drive change control and maintain training metrics and documentation.
• Support audits and inspections with timely documentation.

Skills

EDMS expertise

MS Office proficiency

Technical writing

Independent worker

Cross-functional communication

Attention to detail

ISO 13485 knowledge

MDSAP familiarity

Education

Associate Degree

Tools

MasterControl

Job description

Neuronetics seeks a skilled Document Control Specialist to manage QMS documentation and training within a regulated medical device setting. You will oversee SOPs, records, and training in the EDMS, ensuring alignment with FDA, ISO, QMSR, and MDSAP requirements while collaborating with multiple departments.

The role requires precision, strong writing, cross-functional coordination, and the ability to drive change control and training programs across the organization.