A thrilling opportunity has arisen for a Senior Regulatory Affairs Specialist to join a forward thinking Medical Device company who are pioneering with a broad portfolio. As Regulatory Affairs Specialist, you will work closely with the Senior Vice President of Regulatory Affairs to support the registrations of new products.
Your main missions:
·You are responsible for obtaining the CE marking of your product range (preparation of dossiers
·CE marking techniques, development of the risk management file, monitoring of development projects ongoing, product modifications ...) and the renewal of EC certificates.
·You participate in the establishment of the regulatory strategy.
·You participate in the exchanges with the notified body.
·You are in charge of risk analyses for your product range.
·You are in charge of the post-market follow-up of your range of products and manage the impacts on the files techniques.
·You participate in the management of International Regulatory Affairs.
·You also manage all the proofreading part of promotional materials by ensuring compliance with Regulations in force.
·You are in charge of the regulatory and normative watch and manage the impacts.
·You contribute to the search for synergy with the quality department.
·You hold a scientific Master (biomedical engineer, quality engineer and / or business regulatory...) or a Master in Medical Device
·You have at least 3 to 5 years of experience in a similar position in a design structure and medical device manufacturing
·You know health organizations and are familiar with the European Directive 93/42 / EEC, ISO standards 9001 & 13485 and ISO 14971 with ideally class III product registration
·You have fluent English
This is an incredible opportunity to join an innovative Med Tech company who are well funded and on track to grow exponentially over the coming years. Apply now to learn more.