Quality Assurance and Regulatory Affairs

ID1008

Senior Consultant Quality Assurance and Regulatory Affairs

Ph.D. Molecular Genetics KU
Available for: Part-time

Competences

  • Project management; Prince2 certified.
  • Design control, requirements, design gates.
  • Verification, production transfer, validation.
  • Quality management.
  • Risk management.
  • Design FMEA.
  • Molecular biology, biochemistry, surface modification.
  • GAP analysis: MDD/MDR; IVD/IVDR.
  • Usability.

Key results

2015:
Six medical devices (Class III device and Class I devices) developed and marketed.

2009:
Three different disposable columns for recombinant IgG purification developed and marketed.

2004:
SpotOnTM DNA Micro Array Slide and SpotOnTM Protein Micro Array Slide developed and marketed.

Regulations/Standards

  • 21 CFR part 820
  • ISO 13485
  • ISO 14971
  • Dir. 1998/98/79 EU (IVD)
  • Reg. 2017/746 EU (IVDR)
  • Dir. 1993/93/42 EEC MDD)
  • Reg. 2017/745 EU (MDR)
  • ISO 62366-1

Personal Characteristics

As a Project manager and Design responsible he timely handles and prioritizes project challenges in order to ensure the right delivery and product quality is achieved and validated, according to plan and
stakeholder expectations.

Extensive experience, analytical abilities and commercial understanding combined with teamwork in a positive atmosphere
have delivered impressive results.

He is motivated by ambitious goals, proactive decision making in a busy interdisciplinary QMS and GMP regulated environment and he always see possibilities.

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