Company: Particle3D
Location: Odense

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Odense

Particle3D is a Danish MedTech start-up established in 2017. The company uses a novel class of patent pending technology to 3D print patient fitted bone implants. The Manager, Regulatory Affairs and Quality Assurance is a newly created role within Particle3D to lead the development and implementation of a quality system for a Class II (US) medical device. This position will be responsible for all aspects of Regulatory Affairs and Quality Assurance supported by a experienced QA/RA consultant.

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Keywords

Project Manager

Regulatory Affairs

Quality Assurance

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The successful candidate will play a vital role in bringing our products to market and ensuring that they provide the quality, reliability, and accuracy needed by our patients and customers – and you thrive in an entrepreneurial and fast-paced environment.

The person we seek will demonstrate a thorough understanding of the quality system and regulatory requirements for medical devices and software, a collaborative mindset, and an ability to build business processes that meet international compliance standards while maintaining a high-powered and efficient organization.

  • Lead the development and implementation of a quality system for a Class II (US) medical device
  • Create management metrics to evaluate and monitor effectiveness of quality system
  • Partner with engineering to ensure development plans meet necessary design controls
  • Provide guidance on RA/QA requirements necessary for global expansion
  • Author and oversee documentation packages for submission to regulatory agencies
  • Track timelines and document milestones for inclusion in regulatory submissions
  • Interact with regulatory agencies as part of submission review and on-site audit support
  • Support implementation of new policies by serving as RA/QA subject matter expert
  • Review quality and regulatory content for claims support of promotional material
  • Advise team on changes taking place to applicable global regulations and guidance


Qualifications:

  • A Bachelor’s degree in a related field is required; a scientific discipline is preferred
  • A minimum of 5 years of related experience is required with a bachelor’s degree, OR, a minimum of 3 years of related experience is required with a Master’s degree
  • Hands-on experience developing successful FDA submissions and technical files for medical technology products
  • Experience managing regulated medical technology products with significant software components
  • Experience with Medical Device Data Systems and/or Class II products is preferred
  • Exceptional attention to detail and ownership of work product
  • Enthusiastic team player with an ability to collaborate
  • Highly effective written and verbal communication
  • Good time management and organizational skills
  • Strong ability to problem solving and apply analytical thinking


Perks & Benefits

Flexible work hours and vacation: Morning person or night owl, this job is for you
Free coffee / tea: Get your caffeine fix for free
Located near public transit: Easy access and treehugger friendly workplace
Equity package offer: Want to be a partner? Look no further
Free beer on Fridays: Friday is something special, let’s enjoy a beer together
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