Director Of Regulatory Affairs Jobs in Ohio

Job Title: Associate Director, Regulatory Affairs Company: Guthoff & Associates Executive Search Location: Columbus, OH Description: Columbus Ohio based publicly traded, 26 year old bio-tech manufacturer has a position open in the Regulatory Affairs & Quality Assurance Department. This position reports directly to the VP, RA/QA: to assure the Company's compliance with associated regulatory obligations the individual ensures government and international report systems, documentation and records, comply with regulatory requirements for therapeutic, medical, or diagnostic products by performing the following duties personally, with peers or through subordinate personnel. The individual develops content and format for domestic and foreign regulatory submissions for the Company's device, drug and biologic products; such as but not limited to Investigational new Drugs, Biologic License Applications, New Drug Applications, 510(k)s, PMAs, CTD/eCTD and related supplements and amendments. Reviews regulatory publications to keep appraised of new regulatory developments. As assigned by Supervisor, advises personnel regarding new government regulatory developments. Coordinates with Supervisor and other departments to achieve project goals. As assigned by Supervisor, provides regulatory strategy input to project teams and to peers, and assists in development of project objectives and budgets, and provides training of personnel to regulatory requirements. Prepare regulatory submissions and other regulatory documentation in support of business plan goals and objectives. Prepares international dossier, as well as product registration activities. prepare periodic reports, and various responses to regulatory inquiries. Serves as regulatory affairs representative on assigned teams to provide input for clinical trial filing activities (i.e. Clinical Trials.gov), nonclinical study activities, and to ensure that compliant reporting systems are maintained, consult in preparations and conduct of clinical studies to ensure compliance to regulations in clinical protocol development and final report review for regulatory submissions. Ensure regulatory requirements under marketing authorization or clearance are met. Monitor US and international regulatory environments and provide Management with assessments of the impact of new and changing regulations. Assist in the establishment and maintenance of regulatory documentations, QMS procedures, work instructions and records. Develops, implements, and reviews current policies and practices issued by US and international regulatory agencies. maintains Quality Management Systems and processes to ensure changes to programs, procedures, and processes. As assigned, review and/or investigate customer generated complaints for Company's products (AE/SAE/Pharmacovigilance). This position has limited supervisory responsibilities as assigned by immediate supervisor. Three to five years of significant regulatory experience in the development of biopharmaceuticals or pharmaceuticals, or equivalent combination of education and experience. Technical writing ability and experience filling CTD/eCTD electronic submissions is essential. Demonstrated knowledge of device drug and biologic regulatory requirements associated with the US FDA and other international regulatory agencies' requirements. A college degree in biological sciences is preferred, but not required. Excellent communication, organizational , and project management skills required. Must be familiar with popular business software including Microsoft Access, Word, and Excel. Able to productively and accurately apply Statistical, Database, Design, Internet, Manufacturing, Project Management, Spreadsheet and Word Processing software applications. RAPS-RAC preferred. Working knowledge of FDA, TPB, EMEA, ICH and ISO regulations, guidelines and industry standards. Knowledge of European directives for product registration. Canadian and Japanese regulations for drugs and devices. Must be able to travel 30% of the time,or as circumstances dictate.

Job Title: Regulatory Affairs Manager Company: Confidential Company Location: Cleveland, OH Description: Regulatory Affairs Manager Responsibilities:Serve as a Regulatory Affairs representative on assigned teams to provide input on product development activities. Review and approve changes to procedures, protocols and specifications. Review and approve marketing literature, labels and ads for regulatory content. Review regulatory publications to keep apprised of current new regulatory requirements. Monitor the Federal Register for changes in regulatory agency requirements and makes changes to policies and procedures to conform to changes. Assist and at times lead in the preparation and submission of regulatory filings including 510k's, bi-annual product listings, and small business status for user fees. Review complaints and work with quality and manufacturing to address customer issues. Prepare trending analysis and feed trends into the corrective action (CAPA) system. Work closely with quality on all testing and policies and procedures. Creates all regulatory procedures and updates to remain in compliance with FDA, ISO, European, Canadian, and other standards. Work with the international department on various regulatory filings for product registration in different countries. Provides regulatory support for other projects as required. Requirements:Bachelors Degree required, preferably in Science or Engineering. 8+ years in the Medical industry. 5+ years in Regulatory Affairs. Knowledge of FDA and ISO 13485 regulations a must. Knowledge of international regulatory guidelines regarding GMP requirements is highly preferred. Previous experience creating 510k's desirable. Communications skills Written and Verbal PC Skills

Job Title: Regulatory Affairs Manager (214653-072) Company: Invacare Location: Elyria, OH Description: 214653-072 Job Description Manage adverse event complaint handling process. Manage Corporate Complaint handling system for all North American Invacare facilities in conformance with FDA and Health Canada requirements. Ensure that all potential sources of complaints are reviewed and documented per these requirements. Ensure that adverse event complaint information is reviewed on a timely basis for information which may require reporting to FDA under the MDR Reporting Regulation. Determine if MDR reports are required and submit reports when necessary. Ensure that decisions not to file such reports are justified and documented. Manage investigation and follow-up activity of safety related product issues where injury or the potential for injury has been identified. Ensure appropriate documentation is included in the complaint files. Review complaint responses for adequacy and close out complaint files accordingly. Track progress of recalls and submit monthly updates as required to meet FDA requirements. Participate in Safety Committee meetings and provide updates regarding complaint / MDR activity and recall status. Perform trend analysis and ensure complaint information is communicated regularly to all Invacare personnel who need this information. Submit 510(k) applications to FDA when requested by supervisor and participate in the engineering change control process to provide guidance regarding engineering changes and potential 510(k) or other regulatory impact. Required Skills Four (4) year Technical Degree or equivalent experience. Knowledge and understanding of QSR's and ISO Quality System Requirements. RAC Certification desirable Minimum 5 years Quality Assurance or Regulatory experience in a Manufacturing Discipline. Thorough knowledge of trend analysis reporting techniques and methods. Previous experience in product failure analysis desirable. 3 - years experience with Medical Device Reporting Experience with FDA 510(k) submissions and Part 806 requirements Excellent oral and written communication skills. Some supervisory experience is required. Ability/willingness to travel. Job Location Elyria, OH, US. Position Type Full-Time/Regular

Job Title: Regulatory Affairs Manager Company: Guthoff & Associates Location: Columbus, OH Description: Ohio based publicly traded, 26 year old bio-tech manufacturer has an opening in the Regulatory Affairs & Quality Assurance Department. This position report directly to the VP, RA/QA: Regulatory Affairs Manager ensures all government and international report systems and documentation comply with regulatory requirements for therapeutic, medical, or diagnostic products by performing the following duties personally or through subordinate supervisors. The individual develops content and format for domestic and foreign regulatory submissions for the Company's device, drug and biologic products; such as but not limited to Investigational new Drugs, Biologic License Applications, New Drug Applications, 510(k)s, PMAs, CTD/eCTD and related supplements and amendments. Reviews regulatoryb publications to keep appraised of new regulatory developments. Coordinates with other departments to achieve project goals. As assigned, provides regulatory strategy input to project teams and to peers, and assists in development of project objectives and budgets. Prepare regulatory submissions and other regulatory documentation to regulatory agencies in support of stated business plan. Prepare and submit periodic reports, and various responses to regulatory inquiries. Serves as regulatory affairs representative on assigned teams to ensure that compliance is maintained. Reviews and approves technical data, and verified accuracy of clinical data and execution of clinical projects. Ensure all regulatory requirements under marketing authorization or clearance are met. Monitors the US and international regulatory environments, and provides senior management with assessments of the impact of new and changing regulations. Assist in the establishment and maintenance of regulatory documentation, QMS procedures, work instructions and records. Develops, implements, and reviews current policies and practices issued by US and international regulatory agencies. Maintains Quality Management System and processes to ensure accurate and timely changes to programs, procedures, and processes. As assigned, review and/or investigate customer generated complaints for Company's products (AE/SAE/Pharmacovigilance). This position has limited supervisory responsibilities as assigned by immediate supervisor. Requirements: Three to five years of significant regulatory experience in the development of biopharmaceuticals or pharmaceuticals, or equivalent combination of education and experience. Technical writing ability and experience filling CTD/eCTD electronic submissions is essential. Demonstrated knowledge of device drug and biologic regulatory requirements associated with the US FDA and other international regulatory agencies' requirements. A college degree in biological sciences is preferred, but not required. Excellent communication, organizational , and project management skills required, Must be familiar with popular business software including Microsoft Access, Word, and Excel. Able to productively and accurately apply Statistical, Database, Design, Internet, Manufacturing, Project Management, Spreadsheet and Word Processing software applications. RAPS-RAC preferred. Working knowledge of FDA, TPB, EMEA, ICH and ISO regulations, guidelines and industry standards. Knowledge of European directives for product registration. Canadian and Japanese regulations for drugs and devices. Must be able to travel 30% of the time, or as circumstances dictate.

Job Title: Manager, Regulatory Affairs Company: Avery Dennison Corporation Location: Mentor, OH Description: The Manager, Regulatory Affairs, is responsible for writing, submitting and gaining approval of IDE, PMA and 510(k) submissions to the Food and Drug administration (FDA) for class I and class II products. This position entails being the primary contact with FDA, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive and effective in building working relationships with Product Development teams and the FDA. This individual must adhere to FDA 21 CFR regulations in all duties. Experience should demonstrate dependability, flexibility and professionalism. Individual must be able to travel at least 10-20% of the time. Primary Responsibilities Creating and executing optimized regulatory strategy including study design, protocol development, IDE / PMA submissions, and reports to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement for Class III products. Complete IDE and PMA submissions to FDA, for ultimate premarket approval. Prepare and file FDA reports. Prepare final 510(k) submission and obtain required management approvals. Work with Product Development and management to prepare and review 510(k) submissions. Submit 510(k) documents and responses with FDA in a timely manner. Complete Regulatory Pathway Form (RPF) determinations for all new and revised products, under departmental guidelines. File RPFs and supporting documentation. Review and file Note-to-File documentation for minor changes to 510(k) cleared products or systems. Ensure conformance to 21 CFR regulations. Assist in development of relevant regulatory SOPs.