RA Manager - medical devices

Job content

The CompanyOur client, KiOmed Pharma is capitalizing on a history of innovation and expertise in exclusive chitosanchemistry. KiOmed Pharma, a spinout from KitoZyme, develops a unique pipeline of medical devicesthat address unmet medical needs in high impact pathologies and major social burdens such asinvalidating osteoarthritis, aesthetic medicine and ophthalmology.Located in Belgium, Liège and composed of a fast-growing team, KiOmed Pharma has launched on themarket its first class III CE marked medical device, KioMedineVSone® indicated in the treatment ofsymptomatic patients suffering from knee osteoarthritis. A R&D pre-market pipeline of medical devicesis currently under development, more specifically in dermo-aesthetic medicine and ophthalmologicdiseases.KiOmed Pharma has the ambition and the resources to grow to a worldwide class and aim at succeedingthe commercial launches and growth on its markets.To support and reinforce their team they are looking for a Regulatory Affairs Manager (RA) includingMarket Access from pre market on.The PositionWe have an exciting opportunity for a Regulatory Affairs Manager.The Regulatory Affairs Manager will be responsible for leading the regulatory strategy from preparationof registration dossier to post-market follow-up in order to achieve development and marketing goalsfor medical devices. He/She leads, in collaboration with other departments, the activities related tomarket authorization, registration and vigilance.The Regulatory Affairs Manager will be reporting of the Chief Operating Officer.Responsibilities & AccountabilitiesThe Medical Information Manager is responsible for these overall responsibilities and objectives:

• Support and provide guidance on regulatory issues to internal and external persons on assigned projects.
• Execute or support the preparation and maintenance of new and existing documents required for regulatory approval for assigned projects.
• Gain and maintain regulatory authority approval and manage follow up post-approval activities, including vigilance-related activities, for assigned projects.
• Liaise with regulatory authorities, including notified bodies, as required.
• Participate to product change control activities.
• Monitor legal and regulatory related issues for medical devices, as well as progression in standardization work.
• Report to the upper management on any regulatory update or issue impacting the company activities.
• Ensure documents are produced in accordance with applicable internal and external procedures, guidelines, regulations and standards Experience, Skills and Knowledge
• You hold a University degree (Master or Ph.D) with a scientific (preferably medical or pharmaceutical) or regulatory affairs orientation.
• You have a 5-years’ experience in regulatory affairs.
• You possess a strong knowledge, understanding and experience concerning European regulations and quality systems for medical devices (MDR 2017/745 et ISO 13485). Knowledge and relevant experience in other territories (US, China, Brazil) or regulation for medicines (Directive 2001/83, GMP) will be regarded as an additional advantage.
• You have strong communication and organizational skills. In addition, you are accurate, selfdisciplined, proficient in multitasking and a real team player.
• You have the ability to analyze and summarize scientific and technical information.
• You have the ability to work across function and in a changing environment.
• You have strong oral and written communication skills in English and French. A proficiency in other languages will be regarded as an advantage.

Our clients core values❖ Innovative❖ Teamwork❖ Agile and dynamic