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Medical Device Quality Assurance Specialist

1 month ago

Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time
Job Title: Medical Device QA/RA Consultant

This is a temporary consultancy position to support the company's search for a permanent hire. We are looking for a highly skilled and experienced QA/RA professional to join our Clinical and Regulatory team.

About the Role:

The successful candidate will be responsible for defining and delivering on our strategy to maintain superior product quality and take lead on placing our products on new markets. You will become the expert in all corners of our Quality Management System, engaged in all stages of product development, and help define the structure of technical documentation.

You will play a central role in placing products into new markets, be pivotal in maintaining our products in existing markets, and take part in audits from notified bodies and authorities.

Key Responsibilities:
  • Co-driving product release projects in collaboration with the project manager from the development team
  • Supporting other departments in design control
  • Take lead on the risk analysis for new products, with support from our clinical and development team
  • Reviewing and revising QMS procedures to ensure that they are efficient and effective
  • Assist management in prioritizing regulatory approval activities based on strategy and market potentials
  • Creating and coordinating the product submissions for the devices we develop (possibly supported by consultants)
  • Training of the company in QMS procedures
  • Participate in audits, both internal and external
What We Offer:

As a QA/RA specialist in Radiobotics, you will have the opportunity to work on a wide range of projects, develop your skills and expertise, and contribute to the company's mission to solve the global need for radiologists while ensuring every patient receives expert-level care.

You will join a dynamic and collaborative team, with a positive and can-do attitude, and have the opportunity to work on a variety of projects, from product development to regulatory compliance.

Requirements:
  • At least 1 year experience within quality assurance and/or regulatory affairs
  • Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485, and ideally 21 CFR
  • Experience with Software as a Medical Device
  • Excellent communication skills in English and experience with working within or leading cross-functional projects
  • A master's degree in healthcare, medical or life science
About Radiobotics:

Radiobotics is a company that does what it says. We believe in transparency, integrity, and a positive can-do attitude. We are driven by aspiration, curiosity, and playfulness, and we strive to learn what happens beyond the surface.

We are on a mission to solve the global need for radiologists while ensuring every patient receives expert-level care. Our vision is that all routine X-rays of the musculoskeletal system are augmented and 1st line reported by our products.