Regulatory Affairs & Project Management

ID1057

Regulatory Affairs & Project Management

MSc Nanoscience, Aarhus University
Available for: Part-time, full-time, tasks

Contact us for full CV

Competences

  • Project Management, R&D

  • Design Controls, R&D

  • FDA approval process (PMA, De-Novo)

  • Technical/regulatory writing incl. gap analysis

  • Implants

  • Biocompatibility

  • Sterile barrier systems incl. sterilization

  • Stability (shelf life) / Transportation

  • Audit SME (Design control)

  • Regulatory inquiries

  • Manufacturing problem solving and optimization

Key results

Continuous delivery of projects in accordance with agreed quality, budget and timeline.

Numerous successful regulatory approvals achieved (Class 1s-III), incl. PMA approval in US (class III).

Numerous audits from FDA, Europe and rest of world completed with no observations.

Continuous ability to address and close technical inquiries from competent authorities.

Regulations/Standards/Guidance

Regulations:

  • MDD, MDR, CFR 21 part 820

Standards:

  • ISO 13485 (Quality Standard)

  • ISO 14708-1 / EN 45502-1 (Active implantable medical devices)

  • ISO 14971 (Risk Management)

  • ISO 10993 (Biocompatibility)

  • IEC 62366-1 (Usability)

  • IEC 60601 (Electrical safety)

  • ISO 11135 (ETO Sterilization)

  • ISO 11607-1 (Sterile Barrier System)

  • ASTM D4169 (Transportation)

Personal Characteristics

He is known for his goal-oriented way of working, effortlessly mixing a forward-looking attitude with a special blend of humor and dedication.

His great skill in connecting with team members through strong social abilities creates a team-oriented and pleasant atmosphere at work.

This balance between being professional and light-hearted, together with his focus on good results, clearly marks him as a highly valued and respected team member.

Moreover, his approach to work shows the Danish values of practical thinking, teamwork, and a friendly, personal way of interacting, making him an essential part of any collaborative project.

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