Analyst ensuring compliance with information security policies at CRH Talento in IT. Responsible for monitoring controls and compliance with regulations in the information security sector.
About the role
- Associate Director providing strategic and operational regulatory direction for medical device projects. Collaborating with cross-functional teams for successful global submissions and regulatory compliance.
Responsibilities
- Independently provides strategic and operational global medical device regulatory direction and documentation for projects/products covering design and development, registration, approval and post approval activities.
- Develop and communicate RA MD regulatory strategies for projects across the life cycle (Development and On-Market).
- Ensure device regulatory risks and key issues are communicated in a timely manner to project teams and other stake holders.
- Represent department in cross-functional project teams as appropriate.
- Provide Novartis technical functions clear, concise guidance on current device regulatory requirements to support planning and decision making.
- Lead and implement global Regulatory Affairs Medical Device (RA MD) submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify the required documentation and content, compliance and timelines issues for global submissions and work collaboratively with cross-functional teams for the delivery of technical source documents in accordance with project timelines.
- Author and/or review compliant RA MD documentation for HA submissions, applying agreed RA MD Global regulatory strategies, current regulatory standards and guidelines.
- Lead, prepare and communicate RA MD risk management assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.
- Facilitate/support device related interactions with Health Authorities globally.
- Contribute to knowledge sharing, e.g. provide coaching within RA CMC and other functional areas
- Contribute to the development of new guidance, policy, and processes.
Requirements
- Experience in Medical Device Regulatory Affairs.
- Significant experience in the combination product or medical device industry.
- Proven knowledge of regulatory submission and approval processes for medical devices and combination products.
- Ability to critically evaluate data across diverse scientific disciplines.
- Understanding of product development and lifecycle management.
- Demonstrated success in leading and prioritizing multiple projects in global, cross-functional teams.
- Strong independent working skills with the ability to manage timelines and workload effectively.
- Excellent planning, organizational, and interpersonal skills.
- Proficiency in computer and IT systems.
Benefits
- Commitment to Diversity & Inclusion
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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