Medical Device Manager - Barcelona, España - Asphalion

Asphalion

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

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

Job functions:
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 lifecycle 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

Requirements:

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 substancebased and borderline products would be a strong advantage
Knowledge and / or interest in drugdelivery devices and drugdevice 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)

Permanent contract.