Regulatory Affairs Senior Manager

1 day ago

Santa Rosa, California, United States Medtronic Full time

Regulatory Affairs Senior Manager Job Description

Medtronic Structural Heart seeks an experienced Regulatory Affairs Senior Manager to develop and execute global regulatory strategies for innovative transcatheter valve technologies. This role will report to the Vice President of Regulatory Affairs and oversee a team of professionals.

Key Responsibilities:

  • Develop and implement regulatory strategies for transcatheter valve products and accessories.
  • Oversight of multiple team members working on innovative programs from concept design to market launch.
  • Guidance on the development of regulatory requirements and strategies for clinical and commercial regulatory approvals of Class III implantable products and associated accessories in the US, EU, and Japan.
  • Collaboration with external regulatory authorities and cross-functional stakeholders to ensure alignment of regulatory strategy with business objectives.
  • Leading interactions with regulatory agencies as part of strategy development and support of regulatory reviews.
  • Providing guidance on regulatory requirements necessary for contingency planning and ensuring compliance with all applicable regulations.
  • Lead a team of 6-8 regulatory professionals in support of new product development. Ensure adequate resourcing to support OU goals.
  • Cultivate a safe, inclusive, and engaging work environment.
  • Provide reports or present to Senior Management on progress to OU product submission goals on a periodic basis.
  • Provide Regulatory Guidance as a functional leader on new product registration, modified products, transferred products, and acquisition activities.
  • Provide oversight of regulatory review of advertising and promotion materials to ensure appropriateness of product claims and materials in alignment with local guidance and regulations.
  • Continuously improve operating mechanisms, communication pathways, and processes for efficiency.
  • Work with your team to ensure understanding and alignment of regulatory work to business goals and priorities.

Requirements:

  • Bachelor’s degree with minimum 7 years of regulatory affairs experience in healthcare, medical device or pharmaceutical industries and 5+ years of managerial experience.
  • Or an advanced degree with minimum 5 years of regulatory affairs experience in healthcare, medical device or pharmaceutical industries and 5+ years of managerial experience.

Preferred Qualifications:

  • 10+ years of Medical Device regulatory affairs experience.
  • An advanced degree in Regulatory Affairs or a technical field such as engineering.
  • Deep understanding of regulations and standards in the medical device industry.
  • Proven track record of successful regulatory affairs management.
  • Strategic thinking and problem-solving abilities.
  • Ability to work in a global strategic framework, establish tactical plans, and work in a self-directed manner to drive for results.
  • Attention to detail with proven and effective leadership and command skills.
  • Knowledge of regulatory environment and product regulation fundamentals, knowledge of international environment strongly preferred.
  • Understanding of medical device industry procedures and terminology.
  • Experience in Regulatory Affairs working with global submissions.
  • Strong problem-solving skills and ability to work effectively in a collaborative team setting.
  • Strong interpersonal, influence, communication, project management, and negotiation skills.

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