The Commercial Quality Specialist, QMS/Complaints – Spain supports quality management system (QMS) andcomplaint‑handlingactivities for commercial operations within the French market. This role helps ensure compliance with applicable regulatory requirements, quality standards, and internal procedures, with a strong focus onpost‑marketquality processes. The position playsan important rolein protecting patient safety,maintainingregulatory compliance, and supporting business continuity while partnering closely with Commercial, Regulatory Affairs, and Supply Chain teams.

Key Responsibilities

• Support commercial quality activities related to QMS and complaints, ensuring compliance with regulatory requirements and internal quality standards.

• Manage and support complaint handling processes, including documentation, investigation support, andtimelyclosure.

• Assistwithpost‑marketsurveillance activities, including adverse event reporting and field action support asrequired

• Support implementation and maintenance of QMS procedures, records, and controls within the local market.

• Partner with Commercial, Regulatory Affairs, and Supply Chain teams to support compliant product distribution and lifecycle activities.

• Participate in internal audits, external audits, and healthauthorityinspections asrequired

• Monitor quality issues, trends, and metrics related to complaints and QMS and support corrective and preventive actions.

• Maintainaccuratequality documentation and reports related to commercial quality activities.

Qualifications

Education:

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, ora relateddiscipline (required).

• Advanced degree in a scientific, quality, or regulatory field (preferred).

Experience and Skills:

Required:

• Typically2-4 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry.

• Experience supporting QMS andcomplaint‑handlingprocesses.

• Foundational understanding of quality system requirements and regulatory expectations for commercial operations.

• Experience supportingpost‑marketsurveillance activities, audits, or inspections.

• Strong attention to detail, documentation, and organizational skills.

• Effective communication andcross‑functionalcollaboration skills.

Preferred:

• Experience in medical devices, healthcare, or other highly regulated industries.

• Familiarity with EU MDR and French regulatory requirements (e.g., ANSM).

• Experience working in a multinational or matrixed organization.

• Exposure to health authority interactions or regulatory inspections.

• Quality or Regulatory certifications (e.g., ASQ, RAC).

Other:

• Language: Spanishrequired; Englishproficiencypreferred.

• Travel: Limited; occasional domestic travel within Spain.

• Certifications: Quality or Regulatory certifications preferred but notrequired

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