Product Quality Expert with Regulatory Affairs Experience

4 weeks ago


Århus, Århus Kommune, Denmark The HubDanske Bank Full time
Lead Technical Documentation Specialist

We are seeking a highly skilled and experienced QA/RA specialist to join our Clinical and Regulatory team at Radiobotics. As a Product Quality Expert, you will play a pivotal role in maintaining superior product quality, leading the strategy for placing our products on new markets, and ensuring compliance with regulatory requirements.

As a key member of our cross-functional team, you will work closely with colleagues from various departments to drive product release projects, support design control activities, and lead risk analysis for new products. Your ability to structure tasks efficiently and deliver results on time will be crucial in achieving our goals.

Responsibilities:
  • Co-drive product release projects with the project manager from the development team
  • Support other departments in design control activities
  • Lead risk analysis for new products with support from the clinical and development team
  • Review and revise QMS procedures to ensure efficiency and effectiveness
  • Assist management in prioritizing regulatory approval activities based on strategy and market potentials
  • Create and coordinate product submissions for developed devices (possibly supported by consultants)
  • Train the company in QMS procedures
  • Participate in audits, both internal and external
Requirements:

To succeed in this role, you will need at least 1 year of experience in quality assurance and/or regulatory affairs, with a strong background in the medical device field. Your attention to detail and ability to communicate effectively with colleagues will be essential.

The ideal candidate will possess:

  • A master's degree in healthcare, medical or life science
  • A positive can-do attitude with a thorough and structured mindset
  • Excellent communication skills in English and experience working within or leading cross-functional projects
  • Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485, and ideally 21 CFR
  • Experience with Software as a Medical Device

Our vision is to solve the global need for radiologists while ensuring every patient receives expert-level care. We believe in transparency, integrity, and a culture of continuous learning and growth.

Estimated salary: $80,000 - $110,000 per annum, depending on location and experience. We offer a competitive benefits package, including health insurance, retirement savings plan, and opportunities for professional development.



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