This is a fully remote position, open to applicants in Portugal.

📋 Description

• Collaborate with the Global Head of Certification and Compliance, as well as the QA & RA Manager, to engage with regulatory authorities and certification bodies regarding all technical and regulatory inquiries.

• Offer technical leadership and expertise to the worldwide Medical Devices network, including sales and commercial teams.

• Oversee the team responsible for IVDR product assessment and IVDR IHC.

• Manage the development and execution of processes, including the approval of IVDR Product Assessors and IVDR IHC personnel, as well as ongoing monitoring and re-approval.

• Assist in business development initiatives as needed to support the continuous growth of the in vitro diagnostic medical device sector.

• Pursue personal professional growth and ensure that training records and personal logs are updated to maintain relevant expertise.

⛳️ Requirements

• Extensive experience with (in vitro diagnostic) medical device management systems, compliance, auditing, and assessment techniques for technical documentation.

• Strong interpersonal skills, capable of fostering positive working relationships with medical device teams and office colleagues.

• Solid knowledge of device legislation, harmonized standards, CS, and guidance documents.

• Comprehensive understanding of the conformity assessment procedures specified in medical device regulations.

• Familiarity with the NB’s quality management system, related procedures, and requisite qualification criteria.

• Proficient in preparing records and reports that demonstrate the proper execution of relevant conformity assessment activities.

• Experience managing cross-functional global teams is considered an asset.