Senior QARA Specialist - Pharma Leader Company (60% Telework)

• Senior QARA Specialist.
• Pharma Leader Company (60% Telework) - Vallés Oriental.

Pharma Leader Company

• 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.

• 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...

• 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.