Regulatory Affairs Manager

Regulatory Affairs and QM Manager

Our client is a market leader in the field of electronic medical devices, with offices around the world and a HQ in Europe. 

Their medical devices and products are used to improve quality of life in the areas of physiotherapy,  physio aesthetics, dermatology and many more. 

For the main office in Barcelona, they are looking to strengthen the RA/QM Team with a Manager to oversee regulatory strategies and approvals of the medical device portfolio.

Your Tasks
- Launch of medical devices globally including EU and USA
- Create, control and coordinate the technical documentation for the international approvals of medical devices, taking into account the market specific requirements for 20+ countries (EU, USA, Russia, Brazil, Japan etc.)
- Work closely with internal cross-functional teams to ensure new products are launched quickly and efficiently
- Maintenance and continued improvement of the quality management system including document control and CAPA processes
- Support in the preparation and execution of external audits, in particular for MDSAP

Your profile
- Successfully completed a graduate degree (BA/MA) in Science or Engineering
- Several years of professional experience in the registration and approval of medical devices in EU and globally
- Knowledge of MDD, MDR and FDA requirements are required. Other international regulations (KFDA, CFDA, Japan, Australia,…) desired
- Experience working with electronic medical devices and its applicable standards IEC 60601, IEC 62304, ISO 14971
- Good knowledge of quality management systems and regulatory requirements, i.e ISO13485, ISO9001, MDR & GMP
- Strong and adaptable communication skills with the ability to work with a variety of different stakeholders and internal teams (C-level, production, R&D, Notified Body and country-specific competent authorities)
- Resilience and cultural competence
- Analytical mindset and the capability to step into a PRRC/ technical responsible role
- Excellent command of English & Spanish – both verbal and written.
- Resilience and cultural competence
- Analytical mindset and the capability to step into a PRRC/ technical responsible role

Please apply with your CV or contact the job poster Rebecca Stevens for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.

Rebecca.Stevens@Adaptivelifescience.com

+44 208 638 5376