Medical Device Manager

hace 2 días

Barcelona, España Asphalion A tiempo completo

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 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

**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 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)

Permanent contract.

  • Medical Device Development Lead

    hace 4 semanas

    Barcelona, España Suma Medtec A tiempo completo

    Position: Medical Device Development Lead Level: Mid - Senior Type : Internal, Full-time Location: Spain (work permit provided for non-EU employees, must be willing to relocate) Job description : This is a full-time role for a Medical Device Development Lead with flexible location based in Spain. The position will offer the opportunity to work with a...

  • Senior Medical Device Compliance Strategist

    hace 7 días

    barcelona, España PQE Group A tiempo completo

    A leading consultancy in pharmaceuticals is seeking a Medical Device Compliance Senior Consultant in Barcelona. This role involves ensuring regulatory compliance, supporting QA and RA activities, and managing multiple projects in the medical devices sector. Ideal candidates have over 3 years of experience in the field, expertise in quality assurance, and...

  • Regional Endoscopy Sales

    hace 2 semanas

    Barcelona, España Cook Medical A tiempo completo

    A medical device company is seeking a Regional Business Manager in Barcelona, Spain, to enhance the sales and profitability of its MedSurg division. The role involves guiding team members, setting sales targets, and maintaining relationships with key accounts. Ideal candidates have experience in profit center management in the medical device industry and a...

  • Regulatory Affairs Manager – Medical Devices

    hace 3 semanas

    Barcelona, España Suma Medtec A tiempo completo

    Position: Regulatory Affairs Manager – Medical DevicesLevel: Mid-levelType: Internal, Full-timeLocation: Austria / Spain (work permit provided for non-EU employees, must be willing to relocate)Job description: This is a full-time role for a Regulatory Affairs Manager with flexible location based in Austria or Spain. The position will offer the opportunity...

  • Regulatory Affairs Manager – Medical Devices

    hace 2 semanas

    Barcelona, España Suma Medtec A tiempo completo

    Position: Regulatory Affairs Manager – Medical Devices Level: Mid-level Type : Internal, Full-time Location : Austria / Spain (work permit provided for non-EU employees, must be willing to relocate) Job description : This is a full-time role for a Regulatory Affairs Manager with flexible location based in Austria or Spain. The position will offer the...

  • Regulatory Affairs Manager – Medical Devices

    hace 3 semanas

    Barcelona, España Suma Medtec A tiempo completo

    Position: Regulatory Affairs Manager – Medical DevicesLevel: Mid-levelType: Internal, Full-timeLocation: Austria / Spain (work permit provided for non-EU employees, must be willing to relocate)Job description: This is a full-time role for a Regulatory Affairs Manager with flexible location based in Austria or Spain. The position will offer the opportunity...

  • Business Development

    hace 4 semanas

    Barcelona, España Proarcai A tiempo completo

    Multinational company with more than 50 years of experience in the development and manufacturing of high-precision thermoplastic solutions for sectors such as automotive, medical, electromechanical, industrial, and life sciences. Combining advanced technology, certified processes, and a strong commitment to innovation, quality, and sustainability, working in...

  • Delegado/a Comercial Medical Device CAT

    hace 14 horas

    Barcelona, España Michael Page A tiempo completo

    Delegado Comercial de Laboratorio Farmacéutico Internacional Excelente oportunidad de trabajar como Delegado Comercial de un importante laboratorio farmacéutico internacional fabricante de ácido hialurónico para el sector hospitalario en la zona de Cataluña (Maresme y Barcelona). Descripción de la oferta Gestionar y ampliar la cartera de clientes en la...

  • Raqa Intern

    hace 5 días

    Barcelona, España Neuroelectrics A tiempo completo

    **Who we are**: Neuroelectrics is a creative, high-tech company offering best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities, and create a better life for patients. We are looking for a RAQA...

  • Clinical Project Manager

    hace 2 semanas

    Barcelona, España Proclinical A tiempo completo

    An opportunity has opened for a Clinical Project Manager (Global) to join a medium sized Medical Devices company based in Barcelona, Spain on a permanent basis. This opportunity would suit an "up and coming" individual who is looking to work in a varied position as it's a small team environment, so when the team grows, you'll have the chance to progress...