We are looking for a Regulatory Affairs Manager- Medical Devices with experience within the medecth and/or pharmaceutical industries and team management to join us, someone who loves to take on new challenges, to work in an international environment and who wants to grow with us!
The Medical Devices Manager will be in charge of:
- Supervise a team of Regulatory Affairs Officers with regards the timely and correct execution of projects according to defined timelines
- Develop successful regulatory strategies to ensure timely device approvals, especially in EU and US
- Guide clients in decisions concerning medical device product development, certification / approval and life-cycle maintenance
- Author and review relevant regulatory documentation for CE certification of MDs and IVDs under MDR and IVDR
- Communication with notified bodies and competent authorities
- Establish processes and work instructions
- Mentoring, training and performance management of team
- Scientific academic background (ideally Pharmacy, Human Biology, or Biomedical Engineering)
- +3 years experience in Regulatory Affairs for Medical devices, with expertise in technical documentation preparation and review, requirements for CE certification under new MD and IVD regulations
- Specific knowledge in substance-based and borderline products would be a strong advantage
- Knowledge and / or interest in drug-delivery devices and drug-device combination products would be a plus
- +2 years experience in Team Managment and Project Management
- Fluent English & Spanish
- Strong attention to details and with very good written communication skills
We offer you:
A highly, dynamic & international working environment with employees from more than 15 nationalities.
A professional, inclusive and high-performance work environment to develop your skills and grow your career.
A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
Training and personal development program.
Flexible working schedule - Compacted workday on Friday.
Social Benefits: English lessons, wellbeing programme, flexible remuneration.
Home Office - Barcelona or Madrid Offices (You can work anywhere in Spain!)