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Quality and Regulatory Affairs Lead

2 weeks ago

Århus, Århus Kommune, Denmark The HubDanske Bank Full time
Key Responsibilities

The successful candidate will be responsible for:

  • Collaborating with the project manager to co-drive product release projects.
  • Supporting other departments in design control and process improvements.
  • Leading risk analysis for new products and reviewing/revising QMS procedures.
  • Assisting management in prioritizing regulatory approval activities.
  • Creating and coordinating product submissions and training the company in QMS procedures.
  • Participating in audits, both internal and external, and driving continuous improvement.

About You

  • At least 1 year of experience in quality assurance and/or regulatory affairs.
  • Mastery of quality and regulatory processes within the medical device field.
  • Excellent communication skills in English and experience working in cross-functional projects.
  • Knowledge of quality management systems and regulatory requirements (MDR, ISO 13485, 21 CFR).
  • Experience with Software as a Medical Device.