Medical Devices Regulatory Affairs
Frank has in-depth knowledge of European regulatory requirements for non-active, implantable medical devices for the orthopedic and dental application. His experience includes, amongst others, developing technical documentations, preparing submissions to notified bodies, monitoring of regulatory changes and conducting compliance gap analyses.
He also has sound experience in developing regulatory strategies and managing cross-functional projects. In addition, he was also involved in the transition of his previous company from the role of a legal manufacturer to that of a critical supplier and the associated consequences. This helps him to understand well the needs of the involved stakeholders (legal manufacturer, supplier, notified bodies) and the need for a good cooperation between them.
The key expertise areas of Frank
Medical devices (focus: non-active orthopedic and dental implants):
Medicinal products (focus: pain treatment):
- Planning and coordination of EU-wide regulatory activities (new registrations, change procedures, re-certifications) for class II and III medical devices
- Exchange with EU notified bodies and authorities during registration procedures
- Provision of regulatory advice and strategy during product development and registration procedures
- Regulatory intelligence: Monitoring of regulatory changes, gap assessment and introducing relevant changes into the company (e.g. MDR analysis and implementation)
- Involved in the transition of a company from the role of a legal manufacturer to that of a critical supplier and the associated regulatory consequences for the involved stakeholders (i.e. legal manufacturer, supplier, notified bodies).
- Leading or working in cross-functional project teams with focus on regulatory issues and processes
- Teaching and mentoring of new employees and Junior Regulatory Affairs Managers with focus on regulatory topics
Frank about working at Qserve
- Planning and coordination of EU-wide regulatory activities (new registrations via MRP/DCP, variations, renewals) for medicinal products
- Preparation, revision and electronic management of registration dossiers and documents (module 1) as well as of Label Management documents (e.g. Core Data Sheets, SmPCs)
- Leading of or working in interdisciplinary project teams
- Interface between headquarters, global subsidiaries and external partners
- Exchange with European health authorities
'I like the mixture of dealing with the constantly evolving regulatory requirements and the interactions with our customers and colleagues. In addition, it is very motivating for me that the products whose registration we support serve a medical purpose and therefore help the patient.
I like Qserve’s highly specialized focus on Regulatory, Quality and Clinical aspects of medical devices and diagnostics. I like Qserve’s global and practical approach. I am fascinated by the high level of professional expertise of the Qserve team.'
Before Frank entered the medical device industry, he was responsible for the European regulatory and label management activities for medicinal products in the pharmaceutical industry. This provides him with a good background to also work on device-drug-combination projects.
Frank has a degree and PhD in Biology with a focus on Molecular Biology, Biochemistry and Zoology. This enables him to also deal with IVDs or devices with a biological background.
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