Regulatory Affairs Specialist

2 weeks ago

Tel Aviv, Tel Aviv, Israel CustoMED Full time $90,000 - $120,000 per year

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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