Corporate Senior Medical Device Quality Assurance Specialist

WE ARE HIRING

CORPORATE SENIOR QUALITY SPECIALIST- Medical Device

Neuraxpharm is looking for people who want to make a difference and improve patients' lives within the CNS area. We want individuals who will go the extra mile and make great things happen.

Being part of this team does not mean you are just working for a company, but for a cause

Neuraxpharm is looking for a Corporate Senior Quality Assurance Specialist- Medical Device, based in Barcelona

(Corporate role)

Your mission:

The purpose of this role is to ensure the regulatory and quality compliance of Medical Devices and combination products (MD-Drug) throughout their lifecycle. The position involves leading the implementation of ISO 13485:2016 standards, managing product registrations, and supporting audits and validations in accordance with European regulations. By developing and maintaining robust quality systems and documentation, the role contributes to the safe distribution and continuous improvement of medical products. Acting as a technical and quality reference, the specialist supports affiliates and healthcare professionals, ensuring alignment with corporate objectives and regulatory expectations.

Your major accountabilities:

• Implement and maintain quality standards in line with ISO 13485:2016 and applicable European regulations.
• Lead and support regulatory registrations and authorizations for the distribution of Medical Devices and combination products (MD-Drug).
• Conduct audits and qualify manufacturers and auxiliary suppliers, ensuring compliance with internal and external quality requirements.
• Develop and maintain quality documentation, including SOPs, technical specifications, functional specifications, and market surveillance plans.
• Validate quality processes by establishing product specifications and attributes, documenting evidence, and supporting qualification and validation activities for MDs.
• Ensure compliance with GMP and GDP standards and contribute to continuous improvement of quality systems specific to Medical Devices.
• Provide technical and quality support to affiliates and healthcare professionals, acting as a reference point for product-related inquiries.
• Collaborate with cross-functional teams to identify and resolve quality issues, define KPIs, and implement system improvements.
• Ensure regulatory and quality compliance of Medical Devices and combination products (MD-Drug) by leading the implementation of ISO 13485:2016, managing product registrations, and supporting audits and validations in accordance with EU 2017/745 and Directive 93/42/EEC.
• Develop and maintain technical documentation and quality systems specific to Medical Devices, including SOPs, specifications, market surveillance plans, and providing technical support to affiliates and healthcare professionals. 

We would like you to have:

• Bachelor's Degree in Engineering or Master Degree in Engineering  with specialization in Industrial or Electronic Engineering. A background in the healthcare or life sciences field is highly valued.
• 5+ years of experience in Quality roles managing Medical Devices and MD-Drug combination products.
• Proven track record in achieving ISO 13485:2016 certification and managing regulatory registrations and authorizations.
• Solid understanding of European legislation (EU 2017/745, Directive 93/42/EEC), GMP, GDP, and international certification frameworks.
• Experience in auditing and qualifying manufacturers and suppliers, as well as validating quality processes and product specifications.
• Proficient in developing technical documentation and SOPs specific to Medical Devices, including market surveillance plans.
• Ability to provide technical and quality support to affiliates and healthcare professionals.
• Familiarity with manufacturing models, electronic components, and software applications related to Medical Devices.
• Strong collaboration skills with cross-functional teams to resolve quality issues and drive continuous improvement.

ABOUT US

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.

The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals in Spain.

Be part of the team where you can count on us to deliver:

• Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
• Attractive remuneration according to the experience and skills provided.
• An inspiring leadership team that drives performance.
• An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, dynamic, result focused and an expert & excellent team

Interested in knowing more?

Have a look at what Neuraxpharm culture represents and what makes us a great place to work

If you want to join us, this is your opportunity

WE COUNT ON YOU, YOU COUNT ON US

At Neuraxpharm's we ensure an inclusive, diverse, safe and respectful work environment for everyone in its organization. As we care for our people as much as we do for our patients, we are committed to guaranteeing a healthy, inclusive and equal opportunity workplace that enables employees to develop their professional potential, while ensuring their individual and collective satisfaction.

We are guided by a Diversity & Inclusion policy to ensure a business culture based on the principles of diversity, equality and inclusion. Our policy complies with European legal regulations and includes the necessary standards, processes and measures to be taken in the event of discrimination or harassment against any employee of the company.

We embrace and promote different cultures, gender identities, seniorities, ages and mindsets within the workplace, to bring different perspectives, styles and experiences to our business.