Quality Regulatory Manager

elemed; Madrid; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading medical devices company is searching for a RAQA Lead for the Iberian region, based in Barcelona. The role requires at least 5 years of experience in quality assurance or regulatory affairs within the medical device sector. The ideal candidate will maintain the Quality Management System and manage post-market surveillance operations. Fluency in both Spanish and English is necessary, with office presence expected three days a week. Opportunities to work in a dynamic international environment are available.

Formación

• At least 5 years in a quality assurance or regulatory affairs role in the medical device industry.
• Experience leading RAQA operations or projects for medical devices.
• Fluency in written and spoken Spanish and English.

Responsabilidades

• Maintain the Quality Management System for the Spanish Organization.
• Manage Post-Market Surveillance (PMS) operations and PMCFs.
• Prepare and lead quality management review meetings.
• Support internal and external audits.

Conocimientos

Quality Management Systems

Regulatory Affairs

Clinical Data Collection

Post-Market Surveillance

Bilingual in Spanish and English

Descripción del empleo

Title: RAQA Lead - Spain and Portugal

Location: Barcelona, Spain

Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are always accessible to patients and surgeons on the market? Do you like working with both active and non-active devices?

Here is a rare and great opportunity to join an international leader in surgical technology and be part of this company’s regional growth strategy in Spain and Portugal and be visible at the EMEA-level. As the Regional QARA Lead for the IBERIAN region, you will be based at their Spain branch office in Barcelona, where they have centralised sales, marketing, customer success teams all in one place.

This is a company-critical role and your past experiences in registrations can help the company to reach their business goals for the EMEA region.

This exciting position will give you the opportunity to work in a diverse international environment.

In this role you will be responsible for the quality system of the sales office in Barcelona as well as supporting the registrations for Spain. Furthermore, you are part of the EMEA Quality Assurance and Regulatory affairs team, for this region you will be responsible for collecting clinical data from surgeons to assist the HQ in the US with clinical surveillance.

In this role you will report directly to the Sr Director Quality Assurance and Regulatory Affairs International.

Responsibilities

• Maintain the Quality Management System for their Spanish Organization
• Work with the Regional Commercial leader to ensure the medical device portfolio remain commercially available and compliant
• Manage Post-Market Surveillance (PMS) operations and PMCFs
• Leading clinical data collection and surgeon feedback processes for submission and PMCFs
• Prepare and lead the quality management review meetings
• Training and coaching people in RAQA functions in other EMEA offices on the procedures and processes
• Identify local regulatory requirements and lead impact assessment which is driving quality management system changes
• Execute Local regulatory registrations where necessary
• Supporting internal and external audits
• EMEA regulatory affairs activities concerning importer and authorized representative requirements

Qualifications

• At least 5 years in a quality assurance or regulatory affairs role in the medical device industry
• Led the RAQA operations or projects for medical devices
• Fluent written & spoken in Spanish and English (bonus if Portuguese and Catalan as well)
• Office-presence 3 days per week in Barcelona city-centre

Location & Office Presence

Office-presence 3 days per week in Barcelona city-centre.

Application Process

✉️ If you are interested in this exciting role, please send your application directly to [e-mail].

Only candidates meeting the requirements set out in the role profile above, will be considered in the application process.

Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.