November 27th to December 1st 2022

Ditigec will participate in RSNA

Regulatory Affairs Manager

We are looking for a Regulatory Affairs Manager who will be responsible for formulating and implementing regulatory affairs policies and procedures for our proprietary software medical devices. As Regulatory Affairs Manager you will be reporting directly to R&D Director and leading another member of staff within the dedicated team.

In more detail, He/she will take care of:

  • Define and direct regulatory strategy inlcuding those activities necessary to obtain Product Certifications
  • Ensure that all regulatory activities for stand-alone software are carried out at EU level (Registration and maintenance of EUDAMED and UDI management) and at FDA level (QMS adaptation to FDA requirements, database maintenance and UDI management) in accordance with regulations
  • Ensure that all regulatory activities are carried out at a Global level
  • Oversee technical documentation and its submission
  • Manage relations with Notified Bodies and Competent Authorities
  • Keep constantly up to date with technical standards, laws and regulations
  • Provide compliance training in terms of medical devices design, verification and validation
  • Ensure post-market surveillance (reporting, incidents etc both on domestic and international database)
  • Ensure internal company procedures and regulatory working instructions are up to date
  • Keep documentary evidence produced by departments you collaborate with
  • Ensure accuracy of sw documentation (requirements, management and architecture, testing etc.)
  • Collaborate in sw release and verify relevant evidence is ready when releasing

Requirements

  • Medical engineering degree or equivalent education
  • Knowledge of MDD, MDR, ISO 13485 and Medical Devices CE Marking
  • Regulatory experience within medical device industry
  • Good knowledge of MS Office and computer systems in general
  • English Proficiency
  • Experience in direct management of audits
  • Experience in FDA would be an advantage
  • Previous people management experience is desired

About You:

  • Excellent communication and interpersonal skills
  • Flexible
  • Team player
  • Ability to organize, coordinate and optimize workflow
  • Good at drafting documentation
  • You are resposible, reliable and have confidentiality skills
  • You take initiative
  • Problem solving

Let's work together