Document Control Specialist

Career-defining. Life-changing.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

Additional Job Description

iRhythm Technologies, Inc. is a is a publically held (Nasdaq: IRTC) medical device and healthcare information services company with a proven approach to long-term continuous monitoring that enables diagnosis earlier in the clinical pathway to improve patient outcomes and reduce healthcare costs. iRhythm provides competitive compensation and benefits package.

The Document Control Specialist is responsible for managing and implementing the process associated with creation and revision of iRhythm's Quality System documents. Responsible for maintaining a complaint change control process within the global Document Control System.

• Responsible for overall coordination of controlled documents within iRhythm's global Document Control system
• Maintain and improve processes associated with an electronic document control system within MasterControl Ensures timely completion and version control of all new and revised documentation
• Work cross functionally to ensure change orders are executed in a timely manner
• Responsible to the accuracy of documentation per approved Standard Operating Procedures, GMP and internal change control
• Supports internal and external audits, helps with the coordination of document requests
• Aids in the responses to internal and external audits as they related to the Document Control process
• Supports users requests for documents
• Performs self-audits of satellite controlled binders, and ensures that current revision is available at point-of-use in a timely manner
• Maintains quality records per applicable SOPs
• Responsible for coordinating document change orders (packets), collaboration, approval, release and retention.
• Other duties may be assigned as deemed necessary by management

• Strong communication (verbal and written) and interpersonal skills
• Attention to detail and timeliness are critical
• Computer Skills: software proficiency in Microsoft Office Suite is required
• Previous MasterControl experience is highly desirable
• Must build rapport across functional teams within the organization
• Bachelor's Degree or equivalent experience
• Minimum of 2 years of experience in Document Management System
• Through understanding of the regulations and regulatory processes for document control/ management
• Must operate through collaboration and transparency
• Experience in cGMP/GDP/GCP environments and FDA regulated industries is preferred