Regulatory Affair Manager

vor 3 Wochen

Geneve, Schweiz LHH Vollzeit

Our client is an innovative medtech company developping Class III devices.

**Responsibilities**:

- Lead the review of technical documentation necessary for regulatory submissions in Switzerland, Europe, and United States;
- Create the regulatory strategy for projects and lead the interactions with competent authorities (e.g. FDA, BfArm, Swissmedic, CCMO) and notified bodies to facilitate access to future market approval processes;
- Drive usability and human factors analyses per IEC 62366-1 for Active Implantable Devices and Software as Medical Devices;
- Support scientific and regulatory discussions with internal stakeholders within clinical, medical, regulatory, R&D and business development to drive support of the regulatory and clinical strategy, communicate evidence needs for multiple projects;
- Provide regulatory support for Risk Management per ISO 14971 activities throughout product lifecycle;
- Support clinical investigation and evaluation, literature review with the support of the Field Clinical Research Associate and Contract Research Organization;
- Perform post market surveillance, regulatory intelligence with the support of the Regulatory & Clinical Affairs Engineer.

**Profile**:

- MS in Biomedical Engineering or relevant Life Science discipline;
- At least 6 years of experience in a similar position in the medical device industry - preferably with class III medical devices;
- Experience interacting with Regulatory Authorities (such as FDA, BfArm, Swissmedic, CCMO) and Notified Bodies;
- Detailed understanding of the EU, Swiss and USA medical device regulations, including the MDR 2017/745/EU, MEDDEV 2.7/1 rev 4, FDA 21 CFR Part 820 and ISO 13485 requirements;
- Previous experience developing strategies to generate clinical evidence is preferred (Clinical Evidence Report);
- Fluent in English; proficiency in French a plus.

Permanent contract #RA #Medtech #ClassIII

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