Global Quality & Regulatory Director

BioSystems; Barcelona; On-site; EUR 120,000 - 150,000; Full time

Benefits offered by this job

Innovative work environment

Job summary

BioSystems, a global leader in analytical solutions for IVD and life sciences, is seeking a Quality Director to lead the Quality and Regulatory Affairs function. You will shape strategy and drive robust quality programs across the organization, aligning with regulatory requirements and business goals.

You will manage QA, RA, QC and Analytical Evaluation teams, oversee the QMS, audits, regulatory submissions, and external interactions, mentoring leaders to foster a culture of excellence worldwide.

Qualifications

• Minimum 10 years of Quality/Regulatory Affairs experience in IVD or Life Sciences.
• Strong knowledge of IVDR, ISO 13485, CE Marking and QMS.
• Strategic, hands-on leader with excellent communication and stakeholder management.

Responsibilities

• Define and implement Quality and Regulatory strategy aligned with company objectives.
• Ensure compliance with regulatory requirements and quality standards across global markets.
• Lead the Quality Assurance, Regulatory Affairs, Quality Control, and Analytical Evaluation teams.
• Oversee the Quality Management System, audits, inspections, certifications, regulatory submissions, and external interactions.
• Support product development and lifecycle activities with regulatory and quality input.
• Drive a culture of quality, compliance, accountability, and continuous improvement.
• Monitor regulatory developments and market trends to identify risks and opportunities.
• Partner with cross-functional teams to support innovation and business growth.

Skills

Strategic Leadership

Team Development

Critical Thinking

Change & Transformation Management

Stakeholder Engagement

Education

Degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, Biomedical Sciences, or related field

Job description

BioSystems, a global leader in analytical solutions for IVD and life sciences, is seeking a Quality Director to lead the Quality and Regulatory Affairs function. You will shape strategy and drive robust quality programs across the organization, aligning with regulatory requirements and business goals.

You will manage QA, RA, QC and Analytical Evaluation teams, oversee the QMS, audits, regulatory submissions, and external interactions, mentoring leaders to foster a culture of excellence worldwide.