Quality Assurance & Regulatory Affairs Professional

Location: Barcelona

Scope: Iberia (Portugal & Spain)

Department: Business Services
Contract: Permanent / Full-time

We are seeking an experienced Quality Assurance & Regulatory Affairs Professional who wants to consolidate a career being a part of a leading in vitro diagnostic company that has been growing enormously during the last 15 years.

Join Sysmex, a global leader in in vitro diagnostics, and play a key role in maintaining and improving our Quality and Environmental Management System (ISO 9001 & ISO 14001) across Spain and Portugal. You'll also support our regulatory compliance, sustainability, and CSR initiatives, ensuring smooth operations and alignment with global standards.

Your Responsibilities:

Integrated Management System (QMS & EMS)

• Oversee and maintain the Integrated Quality & Environmental Management System (ISO 9001 & 14001) for Spain and Portugal.

• Act as process owner or deputy for QMS, RA, and HSE processes.

• Ensure correct integration of ISO requirements across departments.

• Provide guidance and respond to internal requests via ticketing tool.

• Lead or support projects in Quality, Regulatory and Environment.

• Promote proper change control practices to ensure QMS integrity.

• Provide onboarding and regular training to other departments on QMS, regulatory and sustainability.

• Monitor KPIs, report outcomes, and support Management Review and Leadership & Planning processes.

• Organise and participate in internal/external audits (including from authorities or third parties).

• Maintain documentation and manage the digital document control system.

• Monitor non-conformities and continuous improvement opportunities.

• Manage customer complaints and satisfaction monitoring.

• Design and implement Quality & Environmental communication plans.

• Coordinate supplier evaluations and environmental legal documentation.

• Identify and assess environmental aspects

Sustainability & Environmental Reporting

• Coordinate and submit environmental reports to local authorities and Sysmex Corporation.

• Collect and consolidate data for sustainability reporting.

Regulatory Affairs

• Act as deputy Technical Responsible Person in Spain and Portugal.

• Ensure communication with health authorities and maintain licenses to operate.

• Approve product releases for imported and third-party products.

• Ensure compliance with local regulatory requirements (IVDs and MDs).

• Supervise technical documentation of distributed/imported products.

• Provide timely support to business units and public tender teams on regulatory questions.

• Register products and ensure vigilance support where needed.

• Oversee control of medical device promotion

What We’re Looking For

• University degree in Health Sciences or a related field.

• Minimum 5 years of experience in Quality & Regulatory roles.

• Solid understanding of ISO 9001 & ISO 14001 standards and audit processes.

• Strong project coordination experience.

• Postgraduate qualification in Medical Devices (IVDR/MDR) is a plus.

• Additional training in Integrated Management Systems is a plus.

• English level B2 or higher.

• Proficient in Microsoft Office, especially Excel.

• Highly detail-oriented with strong organizational and communication skills.

What's in it for you?

• Competitive compensation package in line with job responsibilities and experience

• Flexible Compensation Plan in public transports, restaurants, kindergarden, medical insurance for family, etc

• Flexible working hours and hybrid work model

• Subsidized gym membership

• Health & dental insurance

• Referral program bonus – When you introduce us with people as talented as you

• Baby friendly company

• Excellent, dynamic, and multicultural environment

At Sysmex we are focused on cultivating a diverse and inclusive work environment that encourages collaboration, creativity, and innovation. Sysmex is an equal opportunity employer, we are actively looking for qualified candidates regardless of race, ethnicity, national origin, religion, disability, gender, gender identity, sexual orientation, or age. We celebrate how different perspectives benefit our employees, our products, and our community.