Senior Manager, Regulatory Affairs

4 months ago

Santa Rosa, United States Medtronic Full time

Senior Manager, Regulatory Affairs - Structural Heart & Aortic (hybrid)

The Structural Heart and Aortic integrated operating unit offers minimally invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. 

We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.

This role will be based in either Santa Rosa, CA or Minneapolis, MN.

Careers That Change Lives

Medtronic Structural Heart is seeking an experienced and highly motivated Senior Manager of Regulatory Affairs to play a crucial role in the development and execution of global regulatory strategies for innovative transcatheter valve technologies. Reporting to the Vice President of Regulatory Affairs, this individual will have the opportunity to oversee a team of professionals and contribute to the development of solution-oriented strategies for novel products, ultimately making a meaningful difference in the lives of patients around the world

Interacts with core team leaders and cross functional business leaders in order to expedite approval of new product registrations in priority markets to advance treatment options and market strategy. Ensures operating unit coordination to expand new product registration, clearance, licenses, and approvals in a forecasted and planned manner so global patient access is maintained and expanded. 

Position will lead pre-market submission and registrations for new and existing products for priority markets including US, Japan and EU. Coordinates across the Operating Unit functions, Region Marketing, Country Marketing, and Regional Regulatory to to agree prioritization, develop strategy and accelerate registrations in accordance with all applicable regulatory requirements and in line with business objectives. 

A Day In the Life

Development and implementation of 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, and develop a team of 6-8 regulatory professionals in support of new product development. Ensure adequate resourcing to support OU goals.  Cultivates 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.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. 

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

Nice to Have

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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