What You Can Expect

As a QARA Specialist, you will be part of the EMEA Quality Commercial & Distribution Team within the Commercial Organization.

How You'll Create Impact

Quality Management System (QMS)

• Support implementation, development, maintenance, and improvement of the local QMS (Quality Management System)
• Drive CAPAs and Issue Evaluations
• Participate, provide support and manage quality reviews
• Support with QA/RA standardization of processes
• Work on continuous improvement of our processes

Regulatory Compliance

• Be responsible for product registration, notifications, or renewals and/or regulatory clearance in assigned market in accordance with local in-country regulatory requirements
• Be main contact for the local competent authority. Act as a local regulatory responsible person
• Provide regulatory support to commercial and in-country local commercial teams
• Manage and maintain regulatory documentation, ensuring it complies with applicable regulatory standards and guidelines
• Assist with effective, consistent, and reliable Product Surveillance

Complaint Handling

• Be responsible for complaint handling (submission, coordination of product return, follow-up investigation)

Field Actions (Recalls)

• Liaise with FSCA team and regional stakeholders to initiate recalls
• Handling the Field Safety Notices to the affected customers, reports the reconciliation of products and customers acknowledgment to the PMS team or FSCA Team
• Be responsible for the handling of instructed actions like Field Notices (FN), Product Holds

Audits internal/ external

• Plan, support and join the internal and external audits
• Ensure the Audit preparation activities and support for auditees. Ensure follow-up on Audits (Internal/EMEA/External) as appropriate and required by the internal procedures

What Makes You Stand Out

• Ability to handle high volume of correspondence and prioritize work accordingly
• Ability to work independently and collaboratively in a team-oriented environment.
• Ability to prepare high quality, clear communication materials to the appropriate audience
• Excellent communication and interpersonal skills.
• Ability to work with accuracy and precision.
• Diplomacy and tenacity.
• Discretion and confidentiality
• Ability to work in a multinational team.
• Ability to adapt to changing environment.

Your Background

You hold a B.S. or M.S. degree in biomedical/clinical engineering, pharma, biological or medical science (or equivalent experience) alongside with 5+ years’ experience in registration/notification activities and/or quality assurance in medical devices area.

You have a comprehensive knowledge of regulatory requirements and legislation in Portugal.

In addition you are fluent in Portuguese, Spanish and English.

Travel Expectations

Up to 5%.

The role is ideally based in Barcelona, Spain. Other locations in Spain or in Portugal could be considered.