We anticipate the application window for this opening will close on - 29 May 2026

 

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

As the Regulatory Affairs Manager, you will be responsible for establishing strategy for worldwide product approval submission activities, directly responsible for execution of submission activities focused on US/EU and for ensuring regulatory compliance for Acute Care and Monitoring products. The Regulatory Affairs manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors. This role will require collaboration with business partners to develop regulatory strategies to support the business goals and translate the strategies into work plans for the Regulatory Affairs teams to implement the newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.

Position requires to be onsite 4 days per week in our Lafayette, CO location.

         

         

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

• Provides direction, leadership and coaching to specialists to meet schedules and resolve technical or operational problems.
• Becomes actively involved in daily operations to meet schedules or to resolve complex problems.
• Develop global regulatory strategies for Acute Care and Monitoring products to meet business objectives and collaborate
• across a matrixed organization to ensure global success of products
• 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.
• 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
• Sponsor and actively monitor a high-performance management culture where employees have clear performance
• expectations.
• Provide targeted career coaching and feedback; manage and develop team members at all levels of experience from entry[1]level to Principal.
• Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly.
• Conduct timely and candid performance evaluations. Support meaningful development activities.
• 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.
• 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.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company,
• internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

Required Knowledge and Experience:

• Bachelor’s Degree with and minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.