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Documentation Specialist

Documentation Specialist

LocationEast Coast, United States
Business SectorMedical Devices
Contact nameAimee Brenner
Contact email
Job ref23012
Published19 days ago

Join a leading company in the Medical Device (SaMD) industry as a Document Control Specialist. This crucial role manages and maintains the records required to support the Quality Management System wrt product and product development. 
 

Responsibilities:

  • Lead and continuously improve the Document Management System (DMS).
  • Collaborate with team members to ensure technical documentation and filings are up-to-date and accurate.
  • Manage the maintenance, routing, approval, and storage of both technical and business-related electronic records.
  • Enforce adherence to applicable standards and escalate compliance issues to the appropriate authorities when necessary.
  • Provide support during regulatory, customer, and internal audits.
  • Assist with various tasks related to maintaining and improving the Quality Management System.

Qualifications:

  • Bachelors degree in relevant field (or equivalent experience)
  • 2 - 4 years working in a regulated industry (Medical Device preferred) as a document control specialist
  • Experience creating and maintaining both paper and electronic records
  • Basic knowledge and understanding of Quality System Regulations, including but not limited, to MDR, 21 CFR 11, 21 CFR 820, and ISO 13485.
  • Experience interacting with Regulatory Authorities
  • Excellent written and oral communication skills, including English

 

Practicalities: 

  • Must be available full-time (40 hours per week)
  • Remote position
  • Must be based in the East Coast US Time Zone 
  • Must be eligible to work in the US ( visa transfer is not possible)
Offer:
  • Remote working
  • A unique opportunity to contribute to the regulatory success of innovative medical device products.
  • A dynamic and challenging work environment.
  • Competitive salary and attractive secondary benefits.
 

Application Process:

Interested applicants are encouraged to apply immediately by sending their CV to Aimee Brenner at a.brenner@panda-int.com.