Job Summary

Create, revise, and review product technical documentation (including product design, validation, and regulatory submissions). Review documentation to ensure that all quality and regualtory requriements are met.  Supports activities which lead to and maintain both domestic and international regulatory approval to market devices. In addition, performs a variety of managerial tasks and projects to ensure quality system compliance with US FDA Quality System Regulations, EU IVDR, MDSAP, Canadian Medical Devices Regulations, IVD Directive (98/79/EC), other applicable international medical device regulations and ISO 13485.

Key Accountabilities

• Create, revise, and review product technical documentation (including product design, validation, and regulatory submissions).
• Create, revise, and review company procedures to align with global reguations.
• Learn the company’s products in sufficient detail in order to be able review product documentation.
• Serve as quality technical representative on cross function teams, including product development teams.
• Support revision of technical documentation for IVDR (EU 2017/746) product certification.
• Revise and approve product documentation as needed to support global regulatory submissions.
• Support action item activities related to CAPA and change control.
• Support other quality system activities.
• Stay up-to-date on global IVD regulations.
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

• This role will work often with cross functional teams including the following:
  • Project Management
  • R&D and MTS (Manufacturing Technial Support)
  • Operations
  • RA/QA counter parts globally

Minimum Knowledge & Experience required for the position:

Education:

• Bachelor’s degree in a science related field (ex. biology, biomedical, molecualr biology)

Experience:

• Five (5) or more years of experience in quality assurance in a pharmaceutical or medical device industry. Three (3) years of experience in technical writing. Experience with IVDR technical documentation preferred.
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Experience creating/revising documentation in alignment with global medical device regulations: 21 CFR Part 820, ISO 13485, MDR/IVDR (2017/745 and 2017/46)
• Strong interpersonal, organizational, and communication skills
• Self-starter; ability to participate in cross-funcitional teams
• Ability to set objectives and organize work to achieve goals
• Must be able to work within an evolving environment
• Must be able to accept change to work schedule on a daily basis
• Excellent communication skills, both oral amd written
• Well-versed in Microsoft Office applications
• Experience using MasterControl preferred

Travel Requirements:

• Travel is not routinely required for this position (<5%)