Beschreibung

Stop worrying about MDR delays. Secure your Market Access with an Expert.

With over 8 years of experience in highly regulated industries—including 4.5 years at Bien-Air Dental—I help MedTech companies navigate complex regulatory landscapes and secure certifications for Class IIa/IIb devices.

Why work with me? I don't just "manage" projects; I deliver audit-ready compliance. My dual background in Electrical Engineering and Regulatory Affairs allows me to bridge the gap between R&D and Quality.

Core Expertise & Deliverables:

MDR Transition (EU 2017/745): Gap Analysis, full Technical Documentation (TD) updates, and ISO 13485 alignment.

V&V Leadership (Verification & Validation): Managing the entire product lifecycle (V-model), from requirements traceability to final validation reports (as seen on complex wireless medical systems).

International Market Access: Proven track record in CE Marking, FDA 510(k) submissions, and Wireless compliance (FCC/IC ID) for the US & Canadian markets.

Technical Standards: Deep expertise in IEC 60601-1 (Electrical Safety), IEC 62304 (Software), and ISO 14971 (Risk Management).

My Goal: Transform your regulatory constraints into a competitive advantage by ensuring your technical files are robust, compliant, and delivered on time.

Fluent in English & French. Based in Zurich, available for missions across Switzerland (Zurich, Basel, Geneva) and remote.

Branchenexpertise

Sprachen

Englisch
Verhandlungssicher
Französisch
Muttersprachlich oder zweisprachig

Arbeitsortpräferenzen

Vor Ort möglich

Zurich (bis zu 50 km), Berne (bis zu 40 km), Bâle (bis zu 40 km), Lausanne (bis zu 10 km)

Bien-Air Medical Technologies
Sr MedTech PM | MDR, FDA & V&V Compliance
MEDIZIN
August 2021 - Heute (4 Jahre und 10 Monate)
Biel, VS, Switzerland
Leading the global lifecycle management, V&V, and regulatory strategy for high-end connected implantology systems, wireless medical peripherals, and integrated OEM platforms.

Key Achievements & Strategic Impact:

Flagship Product Leadership (iChiropro): Orchestrated the end-to-end development and maintenance of a smart implantology ecosystem. Managed complex integration between high-precision hardware and software interfaces (iPad/App), ensuring seamless performance in sterile environments.

Wireless Medical Control Systems: Led the global certification and V&V of advanced wireless foot control units. Successfully navigated the intersection of medical safety (IEC 60601-1), battery management, and radio frequency compliance (FCC/IC ID) for the US and Canadian markets.

OEM Platform Integration: Developed a multi-device control platform (HMI) integrating dental chair automation, turbines, and motors. Expertise in managing "System of Systems" complexity and ensuring safe communication between components.

Full MDR Transition & Remediation: Led the conversion of technical documentation for legacy and new-generation devices to EU 2017/745 (MDR) standards. Conducted gap analyses and secured audit-ready files for Class IIa/IIb products.

V&V & Design Controls: Defined rigorous Verification & Validation (V&V) protocols. Expert in translating complex user needs into verifiable technical requirements for hardware/software integration (IEC 62304 & IEC 60601-1).

International Market Clearance (FDA & Global): Secured market access for the US and Canadian markets. Expertise in FDA 510(k) submissions and managing wireless/radio compliance (FCC/IC) for connected medical devices.

Core Tech Stack: Smart Connected Devices, Wireless Medical Peripherals (Radio/RF), SaMD, HMI Systems, MDR, FDA 510(k), IEC 60601-1, IEC 62304, ISO 14971, (Risk Management),V-Model & Agile.
ISO 13485 FDA Gap analysis IEC 62304 MDR 2017/745
MVG
Project Engineer | Technology Programs & Client Delivery
ENERGIE
August 2019 - August 2021 (2 Jahre)
Atlanta, Vereinigte Staaten
Project Engineer - Technology Programs & Client Delivery (USA)

• Spearheaded the deployment of complex technology systems for the North American market. • Acted as the primary interface between US customers and global engineering teams. • Managed on-site installation, calibration, and validation (FAT/SAT) in high-stakes environments. • In-depth exposure to US business standards and technical requirements.
Preisgestaltung Agiles Projektmanagement
NAVAL GROUP
System Engineer | Complex Systems & Program Delivery
VERTEIDIGUNG & MILITÄR
Juli 2016 - Juli 2019 (3 Jahre)
Toulon, Frankreich
• Contributed to large-scale system engineering programs for complex, mission-critical platforms

• Translated client and operational needs into structured system and technical requirements

• Led functional analysis and supported design reviews (preliminary and critical) for integrated systems

• Managed requirement allocation and traceability using structured tools and methodologies

• Coordinated system and hardware integration activities across multiple components and vendors

• Supported factory acceptance testing (FAT) and ensured compliance with cost and delivery constraints

• Acted as technical focal point between engineering teams, suppliers, and end customers

• Participated in internal and client-facing reviews to align requirements, scope, and delivery

• Coordinated technical activities during sea trials and system validation phases