Our team in Barcelona is growing!
Do you want to join us and contribute in the authoring of the technical documentation for the CE certification of a medical device?
The Senior Scientific & Regulatory Affairs Officer – Medical Devices will be in charge of the timely and correct execution of projects according to defined timelines:
- Work with direct reports to develop successful global regulatory strategies to ensure timely device approvals: roadmaps, viability analysis, clinical evaluation, risk management
- Guide clients in decisions concerning medical device product development and promotion
- Collect and coordinate information and prepare regulatory documentation for submission to different regions worldwide (EU, USA, etc.): technical file preparation & review (CE marking), FDA clearance (510(k)) and premarket approval (PMA)
- Communication with notified bodies
- Business development and marketing activities
- Establishing processes and working instructions
- Provide direct supervision of team including mentoring, training and performance management
We offer you:
- A highly professional, dynamic, ambitious & international working environment.
- An organization with highly professional people to develop with.
- More than 12 nationalities!
- A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
- Amazing views of Barcelona from the offices!
- Training and personal development program.
- Flexible working schedule. We enjoy Friday afternoon
- Home Office
- Social Benefits: English lessons/ Flexible remuneration/
- Scientific or engineering academic background
- +3 years experience in Regulatory Affairs – Medical devices (experience in EU & FDA)
- Quality Assurance experience in MD will be a plus
- Fluent English & Spanish
- Proactive, good communication, negotiation and follow up of potential clients.