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Biomedical Engineer - Regulatory Affairs

On-site in Gipuzkoa·Added 17 days ago

Michael Page España

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Overview

Job details

Permanent contract
Per the ad.

Requirements

Have the right to work in Spain
Michael Page España doesn't mention sponsorship in the ad.
Work in English
English is required, per the ad.
Work on-site in Gipuzkoa
No relocation package mentioned.
Have 2+ years of experience
Mid-level role.
University degree
“Grado en Ingeniería Biomédica, Ingeniería de la Salud o titulaciones afines.” — per the ad.

This job was automatically translated to English.

Pay & benefits

What you'll get

Stable incorporation into a growing company in the healthcare sector.
Participation in innovative projects with a direct impact on healthcare.
Professional development within a highly specialized environment.
Continuous training in international standards and regulation.
Competitive compensation package in line with the experience provided.

The role

A company dedicated to the healthcare sector located in Guipuzcoa is looking for a Biomedical Engineer with experience in regulatory affairs.

What you'll do

Guarantee compliance with the regulatory requirements applicable to the company's medical devices, participating in the preparation and maintenance of technical documentation, the management of regulatory registrations, and support for development and innovation projects.

Participate in the regulatory strategy for new products and product modifications.
Prepare, review, and maintain technical documentation in accordance with the European Medical Device Regulation.
Manage technical files for CE marking.
Coordinate activities related to notified bodies and competent authorities.
Collaborate with the R&D, Quality, and Production departments during the product life cycle.
Perform regulatory impact assessments of changes in design, processes, and suppliers.
Participate in post-market surveillance (PMS) and post-market clinical follow-up (PMCF) activities.
Manage registrations and licenses in international markets.
Support internal, external, and regulatory body audits.
Collaborate in the maintenance of the Quality Management System
Monitor regulatory and normative changes applicable to the healthcare sector.

Summary

Experience of at least 2 years in regulation within the healthcare sector
Gipuzkoa

Who are we looking for (M/F/D)?

Degree in Biomedical Engineering, Health Engineering, or related degrees.
A Master's in Biomedical Engineering, Regulatory Affairs, or Quality Management in Medical Devices is valued.
Between 2 and 3 years of experience in Regulatory Affairs within the healthcare or Medical Devices sector.
Experience in the preparation and maintenance of technical documentation for medical devices.
Participation in medical device development projects.
Experience working with MDR requirements and quality systems.
English level B2-C1

Hiring process

2 steps2 interviews

Registro y envío del CV
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Entrevista con la empresa
With an empresa cliente
Si tu candidatura avanza, te ayudaremos a prepararte para la entrevista con información útil sobre la empresa, su cultura y lo que buscan en un perfil como el tuyo.
Fase final y negociación · With an empresa cliente

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About Michael Page España

Michael Page is a global recruitment consultancy and part of PageGroup, one of the world's leading professional recruitment firms. The company specializes in placing mid-to-senior level professionals across a wide range of sectors, including technology, engineering, finance, sales, and human resources. With a strong presence in Spain, Michael Page operates offices in major cities and offers services such as executive search, temporary staffing, and outsourcing solutions.