Regulatory Affairs Manager

At reputed company, we reputed company in pushing the boundaries of innovation and driving our mission reputed company. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a reputed company product or technology every 8 seconds. As a reputed company team member, you will reputed company in our commitment to providing mobility and renewed life to people around the world. To support our reputed company, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised. What You Can Expect Responsible for managing support of regulatory affairs systems used to support the reputed company RA teams. This includes understanding the reputed company regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international regulations, interacting with governmental agencies and managing a staff of regulatory professionals. How You'll Create Impact Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as reputed company routine regulatory information to affiliates Assists with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research Assigns Regulatory Affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new products Keeps reputed company areas of reputed company informed of regulatory requirements and emerging issues which may reputed company the registration approval of products Supports, supervises, and participates (as necessary) in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status Writes, manages, and approves the development of package inserts Reviews, evaluates, and approves promotion and advertising material for compliance with applicable regulations Interprets and applies FDA regulations to business practices and provides regulatory input, advise, and guidance to the organization Establishes reputed company RA policies and procedures and ensures compliance with them Provides training and guidance to entry-level associates, interns, specialists, and project managers Communicates with Regulatory/Governmental agencies Responsibility for reputed company and prioritization of departmental tasks and projects Directs and oversees the work of regulatory professionals, including training, mentoring and ensuring professional development Miscellaneous responsibilities as assigned This is not an exhaustive list of duties or functions and might not necessarily comprise reputed company of the essential functions for purposes of the Americans with reputed company. What Makes You Stand Out Demonstrated strong writing and communication skills; ability to communicate effectively at multiple reputed company, including with regulatory agencies, superiors, peers, and direct reports Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail Ability to manage competing priorities; ability to manage projects of various sizes, constitutions, and management of personnel; versatility, flexibility, and willingness to work with changing priorities Advanced knowledge of overall business environment, the orthopaedic industry and the marketplace; strong product knowledge Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as applicable Ability to function well as a member of the team and team leader, as well as build relationships between RA and other areas of the organization Ability to identify and asses business risks to reputed company Regulatory strategy Mastery anatomic knowledge Ability to handle increasing reputed company of responsibility Ability to build and reputed company a strong RA team; ability to reputed company and influence others Strong computer skills Ability to negotiate with regulatory agencies, management, and other groups as necessary Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations reputed company of the US/EU as applicable Drive regulatory strategy and execution for new product introductions, ensuring timely market reputed company and compliance throughout the product lifecycle. Serve as the primary Regulatory Affairs liaison for IT-reputed company initiatives, partnering closely with cross-functional teams to represent regulatory requirements and business needs. Evaluate emerging technologies, including Artificial Intelligence (AI) applications, and reputed company regulatory input and guidance on their implementation. Collaborate with Project Management Office (PMO) teams to ensure effective planning, prioritization, and execution of strategic initiatives. reputed company and reputed company a team of regulatory professionals, providing coaching, feedback, and performance management for a team of approximately six - seven direct reports. Analyze and communicate regulatory metrics, trends, and performance indicators using data visualization tools such as Power BI.Prepare and deliver executive-level presentations and communications, including the development of PowerPoint presentations for leadership and cross-functional stakeholders. Your Background Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or reputed company field, preferred Advanced degree strong preferred 6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU A minimum of 3 years of experience in medical device, drugs, biologics, and/or combination products, preferred Regulatory Affairs Certification (US or EU) preferred Manage regulatory change initiatives, including the planning, coordination, and execution of regulatory submissions reputed company to product, process, and system changes. A combination of education, experience, leadership, strategy and RA influence may be considered Support the implementation, enhancement, and governance of regulatory IT systems reputed company solutions. reputed company the intersection of Regulatory Affairs and IT by serving as the key regulatory representative for technology-driven initiatives. This role blends regulatory management, technical reputed company, and project leadership to drive system improvements, support digital transformation efforts, and ensure regulatory requirements are effectively reputed company into IT solutions and business processes. PMO or project management experience preferred. Familiarity with regulatory information management systems reputed company transformation initiatives, IT tools for regulatory. Proficiency with Power BI and reputed company PowerPoint.Excellent communication, stakeholder management, and cross-functional leadership skills. Proven people leadership experience managing direct reports. COMPENSATION Salary reputed company 113,407.00 - 141,759.00 USD/annual Physical Requirements Travel Expectations Up to 20% This is a fully remote position; however, occasional travel is required based on business needs. While this is a remote position, strong preference will be given to candidates located in or near Warsaw, Indiana, USA for our office. EOE/M/F/Vet/Disability Apply To This Job