Regulatory Affairs Specialist

2 weeks ago

Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time
About the Role:

This is a temporary consultancy position to support our permanent hire search.

We seek an experienced QA/RA specialist with a strong background in product registrations and quality management systems. The ideal candidate will have a flair for product quality, be curious about new markets, and passionate about medical device software.

The successful consultant will contribute to defining and delivering our strategy for maintaining superior product quality, lead on placing our products on new markets, and become the expert in all aspects of our Quality Management System.

Key responsibilities include co-driving product release projects, supporting other departments in design control, leading risk analysis for new products, reviewing and revising QMS procedures, assisting management in prioritizing regulatory approval activities, creating and coordinating product submissions, training the company in QMS procedures, and participating in audits.

You'll quickly get familiar with our products and previous QA/RA projects within two weeks. After one month, you'll be working on design control projects, participating in risk management activities, and having regular 1:1 meetings with your manager. After three months, you'll be participating in audits, driving CAPAs, communicating with authorities, and planning further development of your professional quality and regulatory affairs skillset.

After six months, you'll be leading our technical documentation, reviewed and approved most types of procedures and quality records, played a significant role in reaching new markets, and developed competitive skills.

Requirements:
  • A minimum of 1 year experience in quality assurance and/or regulatory affairs
  • 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 with 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

You will join our Clinical and Regulatory team and work closely with our Chief Clinical and Scientific Officer. We are looking for someone who can work independently and as part of a cross-functional team in a changing and dynamic environment with tight deadlines.

About Us:

We are a company driven by integrity, transparency, aspiration, curiosity, and playfulness. Our mission is 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 first-line reported by our products, enabling patients to access immediate expert-level evaluation of their imaging.

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