Jr Medical Device R&D Specialist
Description of activities and responsibilities:
- Editing and periodical updating the PMCF documentations in compliance with regulation in force;
- Editing and periodical updating of the Clinical Evaluation documentations, in compliance with regulation in force;
- Cooperates with MD Surveillance to implement and maintain an adequate system in order to collect actively and statistically any significant information concerning performance and safety of marketed medical devices;
- Cooperates with MD Surveillance to propose corrective actions in case of eventual adverse events and incidents;
- Collaborates with R&D Scientific Affairs in propose and manage the activities included in Post-Market Surveillance (PMS) for medical devices;
- Collaborates with Regulatory Affairs Department to verify all information necessary for redacting the documents;
- Collaborates with Regulatory Affairs Department to update medical devices documentations, if required.
- Degree in scientific disciplines;
- At least 1/2 years of experience in medical writing, medical device regulatory affairs and in particular in editing of Clinical Evaluations and PMCF;
- Excellent knowledge of medical device regulations and guidelines;
- Excellent knowledge of written and spoken English
IBSA Institut Biochimique SA, Lugano, Ticino, Svizzera.