* Working closely with the regulatory and clinical team to implement regulatory strategies and secure excellence, and compliance to the new MDR 2017/745
* Full knowledge of Alma systems and accessories and how they meet their intended use and indications including available clinical evidence to support.
* Extended Knowledge of clinical standards and regulations.
* Writing and/or updating CEP&CERs, OMs, PMCF plans and PMCF reports, PSUR to be shared with NB (including biostatistics expertise for sample size determination and trends analysis and rationales)
* Supporting risk analysis process for existing and new projects
* Working with Contract Research Organizations to assist with the regulatory and clinical writing including control of their work and deliverable a setting appropriate expectation to maintain compliance to required standards and regulation.
* Gathering and analyzing regulatory, marketing, R&D, service, sales information to properly update the PMCF database
* Scientific writing
* Review product promotional materials, labeling for compliance with applicable regulations and policies
* Perform gap analysis on updated or new applicable clinical laws, guidelines, standards, and guidance
* Participate in product development meetings, as required, to ensure the product follows all internal and external worldwide clinical regulatory requirements.
* Handling clinical& regulatory aspects of adverse events and vigilance
* Participating on deficiency letters and report to NB
Requirements: * Highly motivated
* Coachable
* At least M.sc in a relevant field (Biology, medical science, bio-engineering etc.); PhD is an advantage
* At least 6 years experience of writing in a clinical affairs/regulatory department (CER/ OM(IFU) / PMCF/ Risk management files/PSUR), in a medical device related company.
* Fluent English. Native English speaker is an advantage!
* Excellent communication skills.
* MS office full proficiency
* A talented writer with attention to detail
* Flexible and has the ability to adapt quickly to changing regulations
* Autodidact
* Excellent organizational, analytical, project management skills
* A team player
* Ability to work under pressure and to meet strict deadlines
המשרה מיועדת לנשים ולגברים כאחד.