Labeling Regulatory Coordinator

Full Time, Temporary/Contract/Project, Employee Job Category: Biotech/R&D/Science Relevant Work Experience: 2+ to 5 Years Career Level: Experienced (Non-Manager) Company: Devon Consulting Contact: Steven Horner Phone: 610-964-5772 Reference Code: D8481 Labeling Regulatory Coordinator Coordinator, Labeling Regulatory AffairsRegulatory AffairsTo manage labeling 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 generation and maintenance of labeling comply with procedures designed to achieve and maintain the product and company quality standards. **Grade 14** ExemptResponsibilitiesManages and establishes timelines for all labeling projects. Participates in product team meetings, contributes to meeting agendas, summaries and reviews meeting minutes and status reports as they pertain to labeling requirements. Identifies issues, seeks resolutions and follows up on action items as assigned. Responsible managing labeling control process for assigned products, including generation of new labeling and changes to existing labeling, and submission of labeling information to regulatory authorities; and implementation of labeling changes into packaging materials. Participation in global teams for activities related to labeling and external communications and related systems. Train, develop, motivate, and mentor product team members in labeling policies and procedures ensuring new team members have awareness of labeling processes. Work directly with Manger, Regulatory in evaluating existing procedures and proposing process improvements to management. Participate or manage the development of labeling SOPs, documentation, and record keeping. Maintains an awareness of global market needs and labeling trends, including but not limited to: published regulations and laws affecting labeling, new or unique printing or production methods, technologies or suppliers for packaging, graphic trends, etc. Responsible for reviewing global and local promotional materials to provide regulatory input with support from Regulatory Manager. Develop and implement procedures for the regulatory aspects of labeling preparation, review, approval and submission. Coordinate the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling. Ensure that new labeling text meets regulatory labeling requirements in conjunction with RA Manager and RA Director. Coordinate submission of labeling materials and supporting documentation to regulatory agencies with the Manager of Regulatory Affairs. Maintain database and archives of labeling materials. 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 in respect to labeling requirements. This includes the implementation of CE marking to products in accordance with IVDD 98/79/EEC. 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. As appropriate, deputy for other members of the RA/QA department. Complete other tasks as assigned by the Manager or SVP, RA/QA. QualificationsFive (5) years progressively responsible related experience in a drug manufacturing, medical device, or biologics industry in a Regulatory Affairs or Quality Assurance position. Supervisory experience, desired. In-depth understanding of labeling processes, package development process, change control procedures and major stakeholder needs, and plant operations. Understands compliance claims (marketing and medical), Trademarks, Formulation and Regulatory manuscripts. Maintains a current awareness of graphics art development tools, including both hardware and software. Maintains a current expertise in print processes and technologies in order to identify opportunities to evaluate/reduce component implementation lead times. Utilize this expertise to educate and advance the overall technical understanding of the artwork development process. Demonstrated expertise in cGMPs, FDA regulations, SOP development. Demonstrated basic computer skills and a working knowledge of basic computer software. MacIntosh & 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. Additional Skills ( not required but preferred) Six Sigma and LEAN EducationBachelors/Undergraduate Degree in quality or science (chemistry, biology, or medical technology) preferred. Work experience within regulatory affairs and professional coursework in lieu of college degree is acceptable. Please send resumes Find An IT Job Find A Clinical Job Click here to learn about the benefits provided to Devon Consultants