We anticipate the application window for this opening will close on - 13 Dec 2024

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In the Neurovascular (NV) Operating Unit, we continuously innovate to provide meaningful tools and technologies to do more for stroke patients. Our comprehensive portfolio provides Neurovascular solutions that advance and enhance care. In addition, we continuously pursue strategic partnerships that round out the continuum of care giving patients the holistic care they deserve through our innovative, integrated solutions.

We work with interventional neuroradiologists, neurologists, neurosurgeons and other stakeholders to optimize stroke treatment. We have the largest portfolio of products for both hemorrhagic and ischemic stroke on the market, allowing us to offer total solutions to our customers.

Reporting to the Neurovascular Operating Unit President, the VP, Regulatory Affairs (RA) leader is responsible for creating an annual and long-term strategic regulatory affairs plan to advance the Neurovascular Operating Unit.

As a member of the Neurovascular Leadership Team, the Vice President of Regulatory Affairs leads a team of regulatory affairs professionals with responsibility for securing and maintaining approvals for a broad set of products and systems supporting a global product portfolio.

The NV portfolio comprises many product classifications including active implantable systems and combination products. As a result, this Vice President of Regulatory Affairs role requires a combination of deep regulatory experience, compliance expertise, technical aptitude, and business acumen. It will be critical that the candidate for this role demonstrates strong knowledge of global regulator expectations and an ability to work directly with the FDA, Notified Body and Competent Authority regulators, as well as closely collaborate on strategy for China along with other global markets. In addition, the role depends on an ability to lead and motivate a large team while building strong global relationships, both cross-functional and with global internal and external regulatory partners.

Responsibilities may include the following and other duties may be assigned. 

• Provide strategic regulatory guidance to business leadership. 

• Develop and implement strategies to achieve timely global commercialization of products in compliance with applicable regulations and standards. 

• Ensure comprehensive and compliant support of released products.  

• Develop and maintain ongoing relationships with global regulatory partners and regulatory authorities. 

• Establish and maintain internal controls to ensure compliance as required by regulatory authorities. 

• Partner across the business and enterprise to continually improve processes related to regulatory activities. 

• Lead a strong, diverse regulatory affairs team with the competencies required to support a global portfolio in an evolving regulatory landscape. 

• Demonstrate an ability to leverage learning and experience therapy-to-therapy in gaining approvals and maintaining approved status. 

 

Must Have: Minimum Requirements 

 

To be considered for this role, please ensure the minimum requirements are evident on your resume. 

• Bachelor’s degree in scientific/technical field required; (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 18 years prior experience in regulatory affairs, clinical, quality and/or product development  

• With Masters or