Regulatory Affairs Consultant in Medical Devices

4 days ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

Radiobotics is a dynamic and innovative company dedicated to solving the global need for radiologists while ensuring every patient receives expert-level care. We are looking for a talented QA/RA specialist to join our Clinical and Regulatory team and contribute to our mission.

The ideal candidate will have a strong background in quality assurance and regulatory affairs, with experience in managing quality management systems and regulatory requirements within the medical device field. You will be responsible for maintaining superior product quality, driving our strategy for placing products on new markets, and collaborating with our clinical and development teams.

Main Responsibilities:

  1. Product Release Projects: Co-drive product release projects in collaboration with the project manager from the development team, ensuring timely and efficient delivery of high-quality products.
  2. Design Control: Support other departments in design control, ensuring that all products meet regulatory requirements and industry standards.
  3. Risk Analysis: Take lead on risk analysis for new products, working closely with our clinical and development teams to identify and mitigate potential risks.
  4. QMS Procedures: Review and revise QMS procedures to ensure they are efficient and effective, aligned with industry best practices and regulatory requirements.
  5. Regulatory Approval: Assist management in prioritizing regulatory approval activities based on strategy and market potentials, ensuring compliance with all relevant regulations and standards.
  6. Product Submissions: Create and coordinate product submissions for devices we develop, possibly supported by consultants, to ensure seamless and efficient submission processes.
  7. Training: Train the company in QMS procedures, ensuring that all employees understand their roles and responsibilities in maintaining superior product quality.
  8. Audits: Participate in audits, both internal and external, to ensure compliance with regulatory requirements and industry standards.

Requirements:

  • At least 1 year experience within quality assurance and/or regulatory affairs, and knowledge that working with quality and regulatory processes within the medical device field is the right path
  • 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


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