Regulatory Affairs Operations Manager Jobs in Indiana

Responsible for managing support of regulatory affairs systems used to support the Zimmer Biomet RA teams. This includes understanding the develop 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.

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 provide 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 all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect 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 Zimmer Biomet 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 oversight 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 all of the essential functions for purposes of the Americans with Disabilities Act.

• Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, 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 develop Regulatory strategy
• Mastery anatomic knowledge
• Ability to handle increasing levels of responsibility
• Ability to build and lead a strong RA team; ability to lead 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 outside of the US/EU as applicable
• Drive regulatory strategy and execution for new product introductions, ensuring timely market access and compliance throughout the product lifecycle.
• Serve as the primary Regulatory Affairs liaison for IT-related initiatives, partnering closely with cross-functional teams to represent regulatory requirements and business needs.
• Evaluate emerging technologies, including Artificial Intelligence (AI) applications, and provide regulatory input and guidance on their implementation.
• Collaborate with Project Management Office (PMO) teams to ensure effective planning, prioritization, and execution of strategic initiatives.
• Lead and develop 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.

• Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related 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 related 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 and digital solutions.
• Lead the intersection of Regulatory Affairs and IT by serving as the key regulatory representative for technology-driven initiatives. This role blends regulatory management, technical oversight, and project leadership to drive system improvements, support digital transformation efforts, and ensure regulatory requirements are effectively translated into IT solutions and business processes.
• PMO or project management experience preferred.
• Familiarity with regulatory information management systems and digital transformation initiatives, IT tools for regulatory.
• Proficiency with Power BI and Microsoft PowerPoint.Excellent communication, stakeholder management, and cross-functional leadership skills.
• Proven people leadership experience managing direct reports.

COMPENSATION

Salary Range 113,407.00 - 141,759.00 USD/annual

Up to 20%