Regulatory Affairs Manager

Exsurco Ohio 10804 Green Road Wakeman, OH 44889, USA Responsibilities Developing and maintaining quality and regulatory systems and system elements in conformity with domestic medical device agency regulations and requirements. Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing regulatory and quality activities, initiating, and executing audits (internal and external); determining system improvements; implementing changes. Meet quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions. Have working knowledge of device and biologic frameworks Design Control and/or Quality by Design. Guide the team through phases, understand documentation and testing requirements, and maintain files. Participate in the development and execution of installation, operational and performance qualifications of equipment (IQ, OQ and PQ) including the clean room itself. Act as UDI information coordinator, including: Managing data within the UDI spreadsheet, including updates due to product changes Completing UDI system data entry throughout the product lifecycle (e.g., GUDID Label Data Entry User, EUDAMED) Responding to regulatory agency questions with support from the Quality/Regulatory Director Managing UDI system access (e.g., GUDID, EUDAMED) Prepare quality documentation (ERTs, CRTs and Management Review) and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re‑validations. Update job knowledge by studying trends and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations (Med Con, ASQ, AAMI). Manage supplier controls through the Approved Supplier List (ASL) and conduct supplier audits. Qualifications BS or BA degree in a life science, or similar with advanced experience in QA/RA areas or related training required. 5–7 years experience in QA and Regulatory Affairs knowledge and direct working experience with ISO and FDA GMPs regulations. Advanced training and certifications related to quality assurance a plus. Skills, Knowledge & Abilities Demonstrated success in leading and developing a collaborative team is essential. Ability to work with Government officials and FDA/ISO auditors. Effective project management skills, excellent interpersonal, verbal, and written communication skills. Ability to exercise authority, manage conflict, and influence others positively. Customer, team‑focused, proactive, and seeks continuous improvement. Ability to remain calm and composed in stressful situations. Ability to work with and communicate well with other groups outside of QA/RA. Ability to lead meetings and small groups. Working knowledge of Microsoft Word, Excel, and Master Control or a cloud‑based quality system. Working knowledge of ERP & PLM systems. Personal Characteristics Behave ethically – understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization. Communicate effectively – speak, listen and write in a clear, thorough and timely manner using appropriate and effective communication tools and techniques. Creativity/innovation – develop new and unique ways to improve function efficiency and performance. Foster teamwork – work cooperatively and effectively with others to set goals, resolve problems, and make decisions that enhance process effectiveness. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr