Regulatory Affairs Manager

95,000.00 - 105,000.00 USD /year Status: Full Time, Employee Job Category: Biotech/R&D/Science Relevant Work Experience: 5+ to 7 Years Career Level: Manager (Manager/Supervisor of Staff) Company: Devon Consulting, Clinical Division Email: Apply by Email Reference Code: D8533 Regulatory Affairs Manager Our client, a biotechnical company located in Bethlahem, PA is seeking a Regulatory Affairs Manager to join them on a permanent basis, to manage activities within the Regulatory Affairs Department ensuring that all goods manufactured and services provided by the company meet the quality requirements of the company, regulatory and notified bodies. Responsibilities 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 Company’s product(s). Provide related training and support to departments as needed. To review Change Control requests, deviation requests, quality system reports for adequacy and compliance with company and regulatory requirements. Responsibility for Biologic Product Deviation Reports in compliance with the Code of Federal regulations. To participate in the investigation of failures and participate in continuous improvement initiatives. Write and maintain procedures relating to the Regulatory affairs function, the preparation and presentation of quality reports, data and Key Performance Indicators for management reviews. To provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports are closed out in accordance with the approved procedure. Participate in the development, management, and maintenance of the Company’s Quality System to meet the requirements of US FDA (21CFR 820 QSR), ISO9001, ISO 13485, EN 13485, MDD, IVDD and all other applicable quality and regulatory standards. Responsibility for ensuring Post Market surveillance/ vigilance systems, liaising with others in the quality departments, QA/QC. Update the RA/QA Director of any serious and/or adverse events. As appropriate, deputies for other members of the RA/QA department. Maintain current knowledge of related trends, regulations, etc. Comply with and maintain the Company’s Quality Systems. Complete other tasks as assigned by the SVP, RA/QA. Qualifications 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. Demonstrated verbal and written communication skills, including the ability to conduct verbal presentations. Demonstrated success working in a team environment. Ability to travel by car and /or airplane typically up to 25%. Additional travel may be required based on business need. EducationBachelors/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 Find An IT Job Find A Clinical Job Click here to learn about the benefits provided to Devon Consultants