Senior Scientific & Regulatory Affairs Officer – Medical Devices

Senior Scientific & Regulatory Affairs Officer – Medical Devices

Senior Scientific & Regulatory Affairs Officer – Medical Devices

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/

Requirements

  • 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.

Send us your CV today or apply here!

Regulatory Affairs Officer