Regulatory Affairs Specialist

The QA/RA Project Manager is responsible for Regulatory Affairs & Quality Assurance.  

Job Description:

·       Lead compiling and preparing materials for submission to regulatory authorities.

Lead Quality Management System (QMS) and medical device development and production, according to the project’s scope and needs.  

·    Coordinate and document internal processes, such as employees training and qualifications, internal audits, Corrective and Preventive Actions (CAPAs) and Management Reviews.

·       Lead and/or support the R&D Team in design control activities and related processes such as Design History File (DHF) maintenance, Verification and Validation (V&V) testing, risk management and change control. 

·       Evaluate, approve, and monitor the customer’s suppliers / clients and sub-contractors.

Required Background:

·       Previous experience in the QA and/or RA fields in the medical device industry including SW. 

·       Relevant University/Professional background (life science, biomedical, biochemistry, etc.) 

Required Skills:

·       Passionate about life sciences, technology, and innovation.

·       Strong communication and interpersonal skills.

·       Highly motivated, committed, and responsible.

·       Ability to work independently, and as part of a team.

·       Willing to learn.

·       Good verbal and written English skills.