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Global Regulatory Affairs Manager Medical Devices

2 months ago

London, Greater London, United Kingdom Novartis Farmacéutica Full time
About the Role

Key Responsibilities:

  1. Develop and implement global medical device regulatory strategies to maximize business benefits while ensuring regulatory compliance.
  2. Lead and support global Regulatory Affairs Medical Device (RA MD) submission activities for assigned projects/products, identifying required documentation for timely global submissions.
  3. Author and/or review high-quality RA MD documentation for Health Authority submission, applying agreed RA MD Global regulatory strategies, current regulatory trends, and guidelines.
  4. Communicate RA MD regulatory strategies, risks, and key issues throughout the life cycle to project teams and stakeholders, representing the department in cross-functional project teams as needed.
  5. Lead, prepare, and communicate RA MD Risk Management Assessments, contingency plans, and lessons learned on major submissions, escalating as necessary.
  6. Initiate and lead Health Authority interactions and negotiations, setting objectives, preparing briefing books, coordinating rehearsals, and risk mitigation plans.
  7. Maintain a single point of contact with global Health Authorities.
Requirements:
  1. Proven experience in medical device & Drug/Device Combination Products regulatory affairs in the pharmaceutical and/or medical device industry.
  2. Strong knowledge and experience in medical device & Drug/Device Combination Products regulatory submissions and approval processes, with understanding of the product development life cycle.
  3. Ability to critically evaluate data from various sources, work in interdisciplinary teams, and prioritize activities, timelines, and workload.
  4. Excellent interpersonal skills and experience working in complex, cross-functional organizations.
  5. Fluency in English.
Commitment to Diversity & Inclusion:

Novartis Farmacéutica is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.