Responsibilities
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- Manage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines

- Participate in the configuration of systems related to product release

- Coordinate communications with Notified Bodies, reference laboratories and related stakeholders

- Manage documentation storage, control and retrieval, including externally archived documentation

- Handle document management quality notifications, ensuring proper tracking and workflow

- Approve quality notifications after evaluating their impact on batch release and product status

- Monitor the status of materials affected by quality notifications

- Coordinate communications with Health Authorities (e.G., AEMPS) regarding import/export activities

- Issue and manage authorizations and official letters required for import/export processes





- Ensure compliance with applicable regulations such as ISO 13485, IVDR and MDSAP

- Act as internal auditor and participate in supplier audits

- Participate in continuous improvement of the Quality Management System.

Requirements

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- Bachelor's degree in Engineering, Health Sciences or similar

- At least 3 years of experience in Quality Assurance or Regulatory Affairs

- Experience in regulated environments under ISO13485 and/or IVDR

- Experience in team management xhfqzwm

- Experience in audits

- Excellent communication skills

- Cross-functional and collaborative work with multiple departments

- Attention to detail and compliance

- Analytical ability and technical judgement in impact assessments

- English level is C1.

Certifications & Qualifications

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- Bachelor's Degree in Engineering

- Bachelor's Degree in Health Sciences

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📌 Qa Product Release Section Manager (Parets)
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