Regulatory Affairs Medical Device
25,000EUR - 50,000EUR
Excellent opportunity to develop your career as a Regulatory Affairs Manager.
Acerca de nuestro cliente
International specialist company focus on developing and distributing hearing medical device.
Descripción de la oferta
- Manages the development of technical files for registration of products (Class lla) in EU and support international registrations.
- Maintains the effectiveness of Company's 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 organization.
- 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
Perfil buscado (h/m)
- 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 (Motivated junior candidates will be considered).
- 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.
- Near native / fluent English.
- EU working permit.
- Capacity to work in an international environment with teams spread in 3 locations.
It will be a plus if you have:
- 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 devicesindustry.
- PhD in STEM or Life/Medical sciences.
- Permanent position.
- Competitive pay.
- Located in our Barcelona R&D facility.