Regulatory & Quality Affairs Specialist (Medical Devices)

dipneo; Barcelona; Híbrido; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A high-growth medical devices company in Barcelona is looking for a Regulatory & Quality Affairs Specialist. This role involves participating in the development of quality and regulatory areas for medical devices preparing for market launch. Ideal candidates will hold a Ph.D. and possess knowledge of quality systems as well as experience in regulatory affairs. The position offers a fixed, full-time contract with a flexible schedule in a hybrid working format.

Formación

• Young Doctor with a degree homogeneous in Spain.
• Specific knowledge of quality systems and/or regulatory affairs applied to medical devices.
• Knowledge of tests applied to medical devices (physical, engineering, biological, medical, ...).

Responsabilidades

• Participate in the development of the quality and regulatory areas of medical devices.
• Collaborate with the company's R&D teams on regulatory and quality assurance aspects.
• Develop/coordinate necessary clinical studies.

Conocimientos

Knowledge of quality systems in health areas

Dynamic person with high capacity for action

Flexible person with continuous adaptation capacity

Educación

Ph.D. in areas of science, health, or engineering

Master's in Regulatory or Quality Affairs

Degree in pharmacy, chemistry, biotechnology, human biology, bioengineering

Descripción del empleo

Regulatory & Quality Affairs Specialist (Medical Devices Development)

DeepTech medical devices company with high growth potential is seeking to incorporate:

A young researcher who wants to direct their professional development in the areas of quality and regulatory affairs in the final phase of medical device development, for market launch in the short-medium term.

Join a highly innovative company, a spin-off of a leading technology center in the medical devices area. The company collaborates with several R&D and development teams from leading institutions.

Functions:

Participate fully in the development of the quality and regulatory areas of the medical devices that the company is developing for market launch. This implies continuous collaboration with the company's R&D teams due to the involvement of regulatory and quality assurance aspects in the advanced phases of research and development of the devices.

Also, participate in the development/coordination of necessary clinical studies.

Opportunity for a professional career with growth expectations in line with the company's growth.

Develop in a dynamic and agile team to adapt to needs, which becomes an opportunity to collaborate and gain experience in various company departments, in addition to the main functions of the position.

Essential Characteristics:

• Young Doctor with a degree homogeneous in Spain.
• Ph.D. in areas of science, health, or engineering.
• Knowledge of quality systems in health areas.
• Degree in pharmacy, chemistry, biotechnology, human biology, bioengineering, biomedical engineering, engineering, and related degrees.
• Master's in Regulatory or Quality Affairs or related fields.
• Specific knowledge of quality systems and/or regulatory affairs applied to medical device or pharmaceutical development companies.
• Knowledge of tests applied to medical devices (physical, engineering, biological, medical, ...)
• Dynamic person with high capacity for action.
• Flexible person with continuous adaptation capacity to the needs that arise in innovative young companies.

Contract Type:

• Fixed, full-time
• Flexible schedule
• Hybrid format (on-site and remote)

Please send your CV and cover letter, specifically indicating your knowledge and experience in the areas of quality and regulatory affairs.