Overview
Senior QARA Specialist
Perfil buscado (Hombre/Mujer) Collaborate in maintaining 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 the 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. Disseminating knowledge about the Quality System and regulatory requirements. Oversee post-market surveillance activities related to medical device products. Offer guidance and mentorship to QARA team members at lower levels. Senior QARA Specialist (Complaints Management) Pharma (Vallés Or) / 60 Telework Engineer, computer Science or other Technical carrier, or equivalent work experience.
Responsibilities
* Collaborate in maintaining 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 the 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.
* Disseminating knowledge about the Quality System and regulatory requirements.
* Oversee post-market surveillance activities related to medical device products.
* Offer guidance and mentorship to QARA team members at lower levels.
Qualifications
* 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 is a plus (IEC 62304).
* Desirable: Knowledge and experience working in medical device regulatory submissions (MDR/IVDR, FDA).
* Good level of Technical and Conversional English.
* Excellent and effective written and verbal communication skills.
* Team player with ability to work independently.
* Pharma Global Company with a software product.
Benefits
Permanent Contract. Competitive Salary. 3 days a week working from home. Flexible Schedule. Multicultural and friendly team. Exciting opportunities for professional development. Ongoing training. Multiple Social benefits: Canteen, health insurance, nursery check, English training.
Keywords
QA, ISO
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