Medical Device Technical Responsible
hace 5 días
Vitoria-Gasteiz
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. As part of our ongoing growth and commitment to excellence, we are currently looking for a Medical Device Technical Responsible to join our international team. This is a unique opportunity to contribute to high-impact projects, working alongside top-tier professionals in an innovative and fast-paced environment. ❗ Please note: Full onsite in Vitoria-Gaseiz for this project's duration; hybrid mode following that (remote and/or from our main office) Responsibilities include, but are not limited to: • Supervise all company activities related to medical devices, including manufacturing, importation, packaging, and/or sterilization., • Ensure that all medical devices comply with applicable regulatory requirements., • Verify the adequacy of the technical documentation and other legally required documents., • Manage and investigate incidents or complaints in line with the company’s post-market surveillance system., • Oversee and maintain implantation cards, where applicable., • Act as the company’s point of contact with health authorities and collaborate during inspections, audits, or regulatory actions., • Provide regulatory documentation to authorities, ensuring product compliance., • Prepare, manage, and supervise marketing or market launch communications., • Prepare and supervise documentation for company registration as a responsible party., • Coordinate and submit clinical trial or clinical investigation applications., • Review and approve advertising and marketing content, ensuring legal and regulatory compliance. Required Qualifications: • University degree in Life Sciences, Engineering, Pharmacy, or related field., • Minimum 6 years of experience in regulatory affairs, quality assurance, or technical roles in the medical device sector., • Strong knowledge of ISO 13485 and EU MDR 2017/745., • Experience with non-active, non-implantable medical devices for wound care and endoscopic applications., • Solid understanding of technical documentation, CE marking, and post-market surveillance., • Excellent communication skills., • Spanish native, English fluent (≥B2)., • Ability to interact confidently with regulatory authorities and notified bodies. Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.
Alexandra E.Activo hace 2 días