Compliance

ID1063

Senior Compliance and Audit Consultant

MSc, Chemical Engineering, DTU
Available for: Part-time, full-time, tasks

Contact us for full CV

Competences

  • Quality Management
  • Medical Device QMS
  • Management representative
  • In- and external audit and inspection
  • Audit Management and execution
  • Supplier Quality Management and audit
  • Quality tools, i.e. CAPA, NCR, MR
  • QMS implementation
  • Lead auditor

Key results

  • Have held positions as VP QA&RA, Director Quality, Director QA and GM Quality
  • I have during my career been responsible for certification and recertification projects, driving audits and inspection, including FDA inspections and MDSAP audits
  • I have been a leader for both small and large teams, including subteams and managers
  • This includes both management and driving all aspects of medical devices compliance and QA
  • I am used to working both nationally as well as truly globally

Software/Standards

Extensive knowledge in:

  • ISO13485
  • FDA 21CFR part 820
  • MDSAP
  • MDR/MDD

Software skills:

  • SAP
  • Documentum
  • Enovia
  • Salesforce
  • MS Office and SharePoint

Personal Characteristics

He is someone who:
– Selfdrive and self motivated
– Work both as a team player or by himself
– Can work with all levels in organizations
– Is driven by seeing the results
– Good business understanding
– Analytical

Whit a background as a chemist, he has spent most of his professional lige within quality.
He have had successes in driving, maintaining and implementing quality systems in a pragmatic way balancing both compliance and business needs.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com