Hearing Technology solutions company is seeking a Regulatory Affairs Manager to join their team in Barcelona
Our client is a Hearing Technology Company that focuses on the development and commercialisation of hearing aid software and hearing support systems.
Your tasks and responsibilities will be manage the development of technical files for registration of products (Class lla) in EU and support international registrations, maintains the effectiveness of Quality Management System, manages regulatory submission processes and communicates with Regulatory agencies, provides regulatory direction to development project teams as a core team member, or lead a project team, develops and communicates regulatory strategy for new products, oversees development of, and may develop and review, proposed labelling for compliance with applicable U.S., EU and international regulations, supports, supervises, and participates (as necessary) in the development of promotion and advertising, material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status of the product, interprets and applies FDA and EU regulations to business practices and provides regulatory input, advice, and guidance to the organisation, keeps all areas informed of regulatory requirements and emerging issues which may affect the registration approval of products, monitoring clinical and user trials and studies.
Requisitos del candidato
De 1 a 3 años
To be considered for this exciting opportunity, you will have a Degree in science, technology, engineering and mathematics (STEM) with experience in areas such as Audio, Computer Science, Electronics, or biomedics, Working knowledge of relevant regulations and standards (i.e. 21 CFR 820, ISO 13485:2016, European MDR, ISO 14971:2012, etc.), Regulatory Affairs training certification is a plus, 2 years of experience in Regulatory Affairs, Mastery of relevant Regulations, and ability to stay abreast of regulations pertinent to medical devices and consumer hearing products, Able to identify and assess business risks and develop Regulatory strategy, Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with Regulatory agencies, superiors, peers, and direct reports, and be capable to work in an international environment with teams spread in 3 locations.
Nice-to-have Competencies as experience working with software medical devices or medical devices that involve software components, understands the overall business environment, medical device hearing industry and hearing consumer devices industry and PhD in STEM or Life/Medical sciences.
Near native fluent English and Fluent in Spanish.
EU working permit.
We offer a permanent position and competitive pay.