Senior Reg Affairs & QA Consultant – Digital Health (Remote)

Complear; Portugal; Remote; EUR 40,000 - 60,000; Full time

Job summary

A leading regulatory consultancy is seeking a Senior Regulatory Affairs / Quality Affairs Consultant. You will support medical device companies with regulatory compliance, focusing on software as a medical device (SaMD) and project management. Ideal candidates will have a graduate degree in engineering and knowledge of EU and FDA regulations. This fully remote position allows you to work with innovative startups and gain hands-on experience in a dynamic sector, driving the success of digital health products globally.

Qualifications

• Experience in preparation of Technical Documentation for Medical Devices.
• Familiar with Medical Device Regulation, ISO 13485, FDA QSR.
• Ability to manage projects and lead stakeholders.

Responsibilities

• Support medical device companies in obtaining CE Mark and approvals.
• Implement Medical Device Regulation (MDR) and In-Vitro Medical Device Regulation (IVDR).
• Compile and systematize technical and clinical information.

Skills

Good communication skills

Computer savvy

English Language Proficiency

Familiar knowledge of EU and/or FDA medical device regulations

Education

Graduate degree in relevant engineering field

Job description

A leading regulatory consultancy is seeking a Senior Regulatory Affairs / Quality Affairs Consultant. You will support medical device companies with regulatory compliance, focusing on software as a medical device (SaMD) and project management. Ideal candidates will have a graduate degree in engineering and knowledge of EU and FDA regulations. This fully remote position allows you to work with innovative startups and gain hands-on experience in a dynamic sector, driving the success of digital health products globally.