SUMMARY

To manage activities within the Regulatory Affairs Department to ensure that all goods manufactured and services provided by the company meet the quality requirements of the company, regulatory and notified bodies. Ensure that all departments involved in the manufacture and sale of product comply with procedures designed to achieve and maintain the product and company quality standards

ESSENTIAL DUTIES AND RESPONSIBILITIES (not inclusive)
    
Manage and organize the Regulatory Affairs department ensuring that departmental objectives are implemented in line with the overall Quality/Corporate goals.

Ensure compliance with the U.S.A FDA Code of Federal Regulations, the European in Vitro Diagnostic Directives, EN 13485 and other Quality Standards as appropriate. This includes, but is not limited to, the design input, review, out-put and verification, validation, transfer and change control.

Provide updates as needed to supervisor regarding regulatory status and requirements, both U.S. and European, of Company products. This includes the implementation of CE marking to products in accordance with IVDD 98/79/EEC.

Compile device master records, technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to CBER and TUV etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses.

Ensure staff understands and complies with the requirements of cGMP as applied to the Companys product(s). Provide related training and support to departments as needed

JOB SPECIFICATIONS:

Bachelors/Undergraduate Degree in quality or science (chemistry, biology, or medical technology).
Five (5) years progressively responsible related experience in a drug manufacturing, medical device, or biologics industry in a Regulatory Affairs or Quality Assurance position.
Minimum 2 years supervisory experience, desired.
Demonstrated experience in development and management of regulatory submissions and documentation including but not limited to BPDR, MDR, facility registrations, IND, 510k.
Demonstrated experience with internal and external audit processes.
Demonstrated expertise in cGMPs, FDA regulations, SOP development.
Demonstrated understanding of Quality Assurance audit functions and Quality Control principles.
Demonstrated basic computer skills and a working knowledge of basic computer software. Microsoft Office preferred.