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.
* Disseminate 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.
Company: Pharma Leader Company (60 Telework) - Vallés Oriental.
Minimum Requirements:
* Engineer, Computer Science or other Technical carrier, or equivalent work experience.
* 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 Conversational English.
* Excellent and effective written and verbal communication skills.
* Team player with ability to work independently.
Employment Details:
* 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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