Sr Regulatory Affairs Manager

Medtronic•Lafayette, CO

15h•Onsite

About The Position

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. 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. Location: Prefer candidate to be in Lafayette, CO. Medtronic leads global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care.

Requirements

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.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

5+ years of medical device regulatory affairs experience
Degree in Engineering or an Advanced degree.
Proven track record of leading high performing teams
Ability to recognize and develop key talent
Excellent knowledge of U.S. and European/International regulations, including EU MDR, and standards for all risk classifications of products
Experience interacting with FDA and/or other regulatory agencies such as Q-sub preparations and meetings, submission issue meetings and other interactions.
Proven ability to prioritize, conduct, and manage time to meet project deadlines
Must work well in dynamic and cross functional team environments.

Responsibilities

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-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.

Benefits

Competitive Salary
Flexible Benefits Package
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)