Compliance and Project Management

ID1081

Medical Device Compliance and Project Management

Mechanical Engineer, MSc, Ph.D. (DTU)
Available for: Part-time, full-time, tasks

Contact us for full CV

Competences

  • Project management, planning and implementation
  • Design and Development
  • Submission- and technical files, DHF and DMR
  • Design Control
  • Vendor and CMO management
  • Compliance (medical devices and Combination products)
  • Geometrical product Specifications
  • Verification and validation of assembly lines
  • Risk assessment, FMECA and control Strategy
  • CC case- customer complaint- and deviation processing
  • Trouble shooting/Root Cause Analysis/A3

Key results

  • FDA and EMA approved combination product
  • Establishment of DHF, DMR and BOM
  • Implementation of Control Strategy for combination product including release tests of Dose accuracy
  • Established state-of-the-art test equipment with associated method development for dimension measurement of primary pack components
  • Planned, specified, implemented, and validated 2 new software applications for DVT test equipment at Novo Nordisk A / S. Meets up to the latest IT standards within 21 CFR part 11 successfully

Software/Standards

  • 21 CFR Part 4 – Regulation of Combination Products
  • 21 CFR Part 11
  • ISO13485 throughout my 20 years of career
  • Veeva Vault: QualityDocs and Veeva QMS
  • ISO2859 and Iso3951:
    Many years of experience with sampling plans and inspections of devices and primary pack components

Personal Characteristics

Is a committed, conscientious, extroverted, and practical person with a positive outlook on life who works with care, uses lots of common sense and does not compromise on quality. Personal qualities are also characterized by good teamwork skills, dutifulness and very result oriented.

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