Regulatory Affairs Technician

• Experience in Regulatory and Clinical Affairs for medical devices.
• Clinical analysis capability and scientific judgment.
• Excellent technical writing skills.
• Ability to technically defend products before auditors and Notified Bodies.
• Ability to work cross-functionally.
• Autonomy, rigor, and quality orientation.

Languages

• Experience in the dental sector (highly valued).

Skills

• University degree in: Medicine, Dentistry, Pharmacy, Biology, Bioengineering, or similar.

o Clinical evaluation under the MDR

o PMS / PMCF

Experience

• Catalan and/or Spanish: advanced level.
• English: advanced level (reading, writing, and technical communication).

• Opportunity to work in a growing team where you can develop your skills.
• Be part of an expanding business group.

Education

We are looking for a Regulatory Affairs Technician for the QA&RA (Quality Assurance & Regulatory Affairs) department at Avinent.

The selected person will be responsible for defining, maintaining, and defending the clinical evaluation, ensuring that Avinent Implant System products are clinically safe, effective, and defensible throughout their entire life cycle, in accordance with the MDR (Medical Device Regulation), and providing support in registering products in new markets.

They will work in close collaboration with the Regulatory Affairs and Quality Assurance teams and will play a key role in interactions with the Notified Body.

Main Responsibilities

• Define and maintain the clinical evaluation strategy for products.
• Prepare, review, and maintain:

o The Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in accordance with the MDR.

• Define, implement, and evaluate the Post-Market Surveillance Plan and the Post-Market Clinical Follow-up Plan and Report
• Contribute as the clinical responsible for:

o The PMS Plan

o The PMCF Report / PSUR

• Clinical defense of:

o The CER and PMCF

What do we offer?

• Specific training in: