Medical Device Technical Pharmacist

Immediate start. Stable position in a leading company in the sector.
Working hours: 8:00 AM to 4:00 PM, with one day per week from 8:00 AM to 5:00 PM; Fridays until 4:00 PM. In July and August, hours are from 8:00 AM to 3:00 PM. (Remote work: 1 day per week).
Location: Madrid (or Bilbao).
Competitive package: €38k - €40k (travel expenses + meal allowance included in payroll). If you are interested, or know someone who might be, please do not hesitate to contact me!

You will join a leading company in the sector, specialized in the marketing and distribution of a wide range of medical devices.

Ensure the application and compliance with legal requirements and good distribution practices established by the European Union, as well as current Spanish regulations applicable at any given time. Lead the proper distribution of medical devices marketed by the company.

Your responsibilities will be:

• Directly supervise import and/or distribution activities of medical devices and communicate these to the Spanish Agency for Medicines and Medical Devices (AEMPS) or the relevant Regional Health Authorities, as applicable.
• Verify that imported or distributed medical devices comply with the requirements set forth by the applicable regulations.
• Submit notifications for placing medical devices on the market or into service through the Spanish Registry of Medical Devices (RECOPS).
• Prepare and communicate, when applicable, imports of medical devices through EUDAMED in accordance with the requirements of the Medical Device Regulation (MDR) 745/2017.
• Release imported medical devices.
• Archive implantation cards for implants that require them and that are returned by hospitals.
• Prepare, safeguard, update, and maintain the documentary archive of medical devices imported and/or distributed within the national territory, making it available to the competent health authorities for the period established by current legislation.
• Establish and maintain a medical device surveillance system.
• Act as the point of contact with health authorities and collaborate with them in implementing any necessary measures, such as product recalls from the market.
• Prepare applications for health authorization and directly supervise clinical investigations.
• Adapt work procedures related to the import, storage, and distribution of medical devices, and supervise them to ensure compliance with the new MDR 745/2017.

• Permanent position as a Technical Specialist Responsible for Medical Devices

Degree in Pharmacy.
Demonstrable professional experience of at least 3 years in the sector, ideally in Medical Devices.
Languages: Advanced level of English.
Other skills: Advanced knowledge of healthcare sector legislation. Knowledge of Quality. Knowledge management and technical skills.

We are looking for a true professional with passion and a strong service vocation!