Job Summary:
Johnson & Johnson MedTech is a leader in healthcare innovation, aiming to improve health for humanity. The Manager, Data Analytics, is responsible for leading regulatory data analytics and reporting activities, transforming complex data into actionable insights to support informed decision making and regulatory strategy execution.
Responsibilities:
• Lead Regulatory Affairs data analytics activities, including development of dashboards, reports, and performance metrics.
• Analyze regulatory and compliance data to identify trends, risks, and opportunities for improvement.
• Partner with Regulatory Affairs, Quality, IT, Project Management, and other business stakeholders to define data requirements and ensure data accuracy and integrity.
• Provide inputs to and distill and interpret the information from the Strategy, Governance, and Insights team.
• Understand the regulatory data, meanings of the data, and implications of the data to identify opportunities for Regulatory Affairs and support regulatory operations and leadership with insights to inform strategic and operational decisions.
• Establish and maintain data governance standards, reporting frameworks, and analytics best practices.
• Support audits, inspections, and internal reviews by providing accurate regulatory data and analysis.
• Monitor evolving regulatory data and reporting requirements and assess impacts on analytics solutions.
• Drive continuous improvement initiatives to enhance regulatory analytics capabilities and efficiency.
Qualifications:
Required:
• Education: Bachelor's degree in data Analytics, Information Systems, Regulatory Affairs, Business, Life Sciences, Engineering, or related discipline (required).
• Advanced degree in Analytics, Data Science, Business, or related field (preferred).
• Typically, 6-8 years of progressive experience in regulatory affairs, data analytics, reporting, or business intelligence within a regulated industry.
• Experience developing dashboards, reports, analytics, and data and technical presentations to support regulatory or compliance functions.
• Strong analytical skills with the ability to translate data into actionable insights.
• Experience working with data visualization and analytics tools (e.g., SmartSheet, PowerBI).
• Ability to manage complex data sets from multiple sources, insight to spot and resolve data conflicts, attention to detail to ensure data quality, and perspective to ensure data governance.
Preferred:
• Experience in medical devices, healthcare, or other highly regulated industries.
• Familiarity with US, EU, and global regulatory processes and compliance metrics.
• Experience leading or supporting regulatory submissions, audits, inspections, technical interactions, or reporting activities.
• Experience working in a global or matrixed organization.
• Demonstrated experience driving data or analytics process improvements.
• Strong stakeholder management and communication skills.
• Language: English required. German, French, Japanese, and Chinese a plus.
• Travel: Limited; occasional domestic or international travel.
• Certifications: Analytics, data visualization, or regulatory certifications preferred but not required.
Company:
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology. Founded in 1886, the company is headquartered in New Brunswick, New Jersey, US, , with a team of 10001+ employees. The company is currently Late Stage.