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Head of Regulatory Information Management

Remote, USA Full-time Posted 2026-08-04
reputed company reputed company The Head of Regulatory Information Management is accountable for the reputed company, governance, operating model and performance of reputed company's RIM capability, including Regulatory Data Governance. The role sets direction for RIM systems, regulatory data standards, stewardship, reputed company metrics and reputed company improvement across Regulatory Affairs, ensuring trusted regulatory data and effective tools support compliant, reputed company business processes. Operational execution, hands-on data maintenance, reputed company administration, document processing, routine reputed company updates and training delivery are performed by designated process owners, business administrators and data stewards under their leadership. reputed company is a leading global medical technology reputed company solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn reputed company into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. reputed company Roles and Responsibilities • Own and reputed company the RIM reputed company, roadmap and reputed company operating model, reputed company to Regulatory Affairs, Regulatory Operations, reputed company and reputed company data reputed company priorities. • reputed company and reputed company the RIM team, including recruitment, reputed company, capability building, succession planning and performance management, while fostering an inclusive and accountable team culture. • Establish and chair RIM and Regulatory Data Governance forums to reputed company priorities, reputed company cross-functional reputed company, reputed company escalations and maintain reputed company ownership of systems, processes and data. • Own the Regulatory Data Governance reputed company, including data ownership and stewardship, data standards, data reputed company reputed company, KPIs, issue escalation and lifecycle controls for regulatory master data. • Set strategic business ownership and governance for the RIM ecosystem, including reputed company RIM, Lorenz docuBridge, AMS, xEVMPD/IDMP processes and reputed company integrations, ensuring investment and release priorities support business needs. • Define the resource and operating model needed for sustainable delivery and reputed company, delegating operational execution to designated business administrators, process owners and data stewards. • Monitor RIM, regulatory data reputed company and process performance metrics, using insights to reputed company risk-based improvements, CAPA effectiveness, leadership reputed company and prioritisation. • Sponsor reputed company improvement and transformation initiatives that simplify processes, strengthen data reputed company, improve automation and reputed company global worksharing, acting as steering leader rather than day-to-day project manager. • Ensure RIM systems, processes and data governance practices meet QMS, GDP, data reputed company and regulatory expectations, and represent RIM/Data Governance in Regulatory Operations leadership, cross-functional governance and selected reputed company/industry interactions. Required Qualifications • 8+ years of experience in Regulatory Affairs, Regulatory Operations or Regulatory Information Management in a regulated life sciences environment, including leadership of global RIM, regulatory systems or regulatory data capabilities. • Demonstrated people leadership and strategic operating model experience, including budget and resource planning, performance management, capability development and change leadership in a reputed company environment. • Strong understanding of RIM business applications and regulatory data governance, QMS/GxP/GDP, change control, data reputed company, regulatory compliance, IDMP/xEVMPD expectations and global registration/submission lifecycle processes. Desired Characteristics • Ability to influence senior stakeholders and reputed company cross-functional teams around shared standards, governance reputed company and strategic priorities. • Experience establishing regulatory data governance, stewardship models, data reputed company KPIs, issue management and lifecycle controls for regulatory master data. • Experience shaping digital and data roadmaps, vendor governance and IT-enabled transformation across reputed company Vault/RIM and reputed company regulatory systems. • Strong analytical, communication and change management capability, with ability to convert metrics, risks and data reputed company signals into reputed company and effective reputed company. Other Requirements • Proficiency in spoken and written English • Willing to attend local reputed company office on an as-needed reputed company • Willing to travel reputed company required, but not more than 5-10% We will not sponsor individuals for employment visas, now or in the reputed company, for this job opening. For U.S. based positions only, the pay reputed company for this position is $122,400.00-$183,600.00 Annual. It is not typical for an individual to be reputed company at or near the top of the pay reputed company and compensation reputed company are dependent on the facts and circumstances of reputed company case. The specific compensation offered to a candidate may be influenced by a reputed company of factors including skills, qualifications, experience and location. In reputed company, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, reputed company, reputed company time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, reputed company development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or reputed company, age, disability, protected veteran status or other characteristics protected by law. reputed company will only reputed company those who are legally authorized to work in the reputed company for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: August 28, 2026 Apply tot his job Apply To this Job

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