Manager Of Regulatory Affairs Jobs in Ohio

Job Title: Regulatory Affairs Manager Company: David Anthony Group, Inc Location: Cleveland, OH Description: Regulatory Affairs Manager Cleveland, OH This position will manage a function and be a hands-on person. Have both domestic and international experience 7 years of Regulatory Affairs and Compliance background FDA 510(k) submissions and applications experience Analyze, evaluate, verify and organize information/data and write/prepare documentation and submissions for the purpose of obtaining clearance/approval for legal market distribution Balance multiple projects and responsibilities effectively Investigation and follow-up activity of safety related product issues. B.S. in Engineering is strongly preferred. Previous medical device background required. Relo assistance

Job Title: Manager, Quality & Regulatory Affairs Management Company: Cardinal Health Location: Zanesville, OH Description: JOB TITLE:Manager, Quality Regulatory Affairs ManagementAt Cardinal Health, were developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.Function:Quality Regulatory AffairsFamily:Quality Regulatory Affairs ManagementWhat QRA Management contributes to Cardinal HealthQuality Regulatory Affairs Management is responsible for strategic oversight and leadership direction within the Quality Regulatory AffairsfunctionThe primary function of the Manager, Quality Assurance and Regulatory Compliance is to manage the Quality Assurance department by effectively overseeing functions of the QA support staff.The position requires managing and reporting of quality issues and troubleshooting problems, as well as some aspects of pharmaceutical labeling. The Manager also supports internal, corporate and regulatory agency audits, vendor audits, validation efforts, new product introduction, method drafting and revisions, as well as special QA/regulatory projects as assigned by the Director, QA/Regulatory Compliance. Interaction with all levels of management as well as outside consultants and regulatory agency inspectors is required.

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: ASSOCIATE DIRECTOR, REGULATORY AFFAIRS Company: Abbott Nutrition Products Division Location: Columbus, OH Description: Primary Function/Primary Goals/Objectives: Develop and communicate global regulatory strategies and implementation plans for innovations, including new products, ingredients, packaging, and processing technologies. Contribute to product development teams as the global regulatory lead for product innovations. Guide claim substantiation for compliance with regulatory requirements; review and approve claims.Major Responsibilities:1. Lead and manage regulatory contributions to new product and technology development teams and initiatives, providing global regulatory feasibility assessments for due diligence and commercial research efforts; collaborate with Abbott affiliate regulatory colleagues to integrate country-specific regulatory focus.2. Lead the development and implementation of global regulatory strategies and submissions for new products and technologies.3. Develop and communicate regulatory strategies for new product/ingredient benefit claims.4. Guide substantiation for regulatory ingredient/product classification, e.g., medical food.5. Provide strategic input to R&D and commercial initiatives to ensure promotions meet regulatory requirements.6. Interface with regulatory authorities on substantiation requirements, regulatory pathway assessment and issues related to success of regulatory submissions.7. Ensure compliance with Abbott SOPs regarding reports, publications and regulatory submissions.Supervisory/Management Responsibilities:Guide and manage Abbott teams/colleagues in the development of data required for regulatory submissions. Manage internal and external contributions to regulatory data development programs.Accountability/Scope:1. Accountable for providing strategic regulatory perspectives and scientific substantiation required for global product introductions.2. Accountable for ensuring an effective, collaborative relationship with internal stakeholders, external regulatory consultants, ingredient suppliers and regulatory agencies.3. Accountable for management of resources and priorities to ensure timely, high quality deliverables that meet project deadlines.4. Accountable for compliance with internal SOPs and with understanding and assuring compliance with relevant global regulations.