Regulatory Affairs Specialist
6 days ago
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.
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