Sr. QARA Specialist (Complaints Management)-Pharma (Vallés Or)

• 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.

• 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 Conversional English.
• Excellent and effective written and verbal communication skills.
• Team player with ability to work independently.

• 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...

Page Personnel