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Senior Diagnostic Specialist

Senior Diagnostic Specialist

beBeeRegulatorylliçà d'amunt, España
Hace 8 horas
Descripción del trabajo

Quality Assurance and Regulatory Specialist

We are seeking a skilled Quality Assurance and Regulatory Specialist to join our team.

Job Description

Key Accountabilities :

  • Maintain the 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.

Requirements :

  • 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).
  • Desirable knowledge and experience working in Medical Device Regulatory Submissions (MDR / IVDR), FDA, Internal Auditor qualification for Management Systems or knowledge of auditing techniques.

    • Skills and Qualities

    Required Skills and Qualifications :

  • Good level of technical and conversational English.
  • Team player with ability to work independently.
  • Excellent written and verbal communication skills.
  • Excellent interpersonal skills.
  • Good judgment and analytical skills.
  • Effective time management and organizational skills.

    • Benefits :

  • Meaningful project that will impact the quality of laboratory software medicine worldwide.
  • Flexible working arrangements (3 days a week from home).
  • Opportunities for professional development and ongoing training.
  • Full social benefits package.

    • Our Purpose :

    We contribute to the advancement of patient care around the world through innovative specialized diagnostics.

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