Software Compliance Specialist

Highly skilled Quality Assurance and Regulatory Affairs professional required to ensure regulatory compliance and certification of software products within a medical device environment.

Maintain quality system documentation processes and procedures adopted by the company.

Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence.

Coordinate and support the preparation of software technical documents appropriate for regulatory submissions.

Support regulatory submissions for market authorization for medical device products.

Conduct internal assessments and audits to identify areas for improvement and ensure adherence to established procedures.

Facilitate the approval process for software releases.

Disseminate knowledge about the Quality System and regulatory requirements.

Review promotional and advertising materials.

Oversee post-market surveillance activities related to medical device products.

Offer guidance and mentorship to team members at lower levels.

Bachelor's degree in Engineer, Computer Science or other Technical field.

A minimum of 5 years experience in Quality Assurance or Regulatory related, preferably within the Healthcare sector.

Knowledge and experience working with medical device international regulations and related standards (ISO 13485, ISO 14971,..).

Knowledge and experience working in Medical device software life cycle process (IEC 62304).

Desirable : Knowledge and experience working in medical device regulatory submissions (MDR / IVDR,FDA..).

Internal auditor qualification for management systems or knowledge of auditing techniques.

A meaningful project that will impact the quality of laboratory software medicine worldwide.

Flexible work arrangement - 3 days a week remote work option.

Multicultural and friendly team environment.

Opportunities for professional development and growth.

Ongoing training and education.

Social benefits including canteen access, nursery check, and English training.

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