Senior Regulatory Affairs Director

Medtronic • Minneapolis, MN

9d • 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. A Day in the Life 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. Cardiac Ablation Solutions (CAS) is one of the Operating Units within the Cardiac portfolio at Medtronic. At CAS, we are developing next generation medical technologies that treat patients with abnormal heart rhythms. Our technologies save lives and improve the quality of living for millions of patients across the world by advancing innovation for the diagnosis and ablation of cardiac arrhythmias and enabling clinicians to perform procedures with superior outcomes. The CAS business is projected to have solid growth, and this role will be critical in enabling our business to achieve our objectives to drive innovation, accelerate product introduction and lead the adoption of CAS driven therapies in the market. In this role as the Sr Director of Regulatory Affairs you will lead a team of regulatory affairs professionals for the Affera platform. This 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 be able to demonstrate an ability to work effectively with FDA and EU notified bodies on Class III products, implement regulatory strategies and maintain compliance. Ability to lead and motivate a team while building strong global relationships, both cross-functional and with global internal and external regulatory partners. Interpret regulatory requirements and effectively communicate internally with cross functional leadership. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

• 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)
• minimum 15 years prior experience in regulatory affairs, clinical, quality and/or product development
• With Masters or other advanced degree, minimum 13 years prior experience in regulatory affairs, clinical, quality and/or product development
• Minimum of 10 years of managerial experience

Nice To Haves

• 10+ years of Regulatory Affairs experience preferred, ideally in the cardiovascular space. Experience in other related functions such as clinical, quality or product development may be considered
• Regulatory / Compliance Expertise Extensive regulatory knowledge and experience across a wide variety of product classifications; including higher classification devices (i.e. Class III PMA, Class III EU).
• Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities
• Ability to apply experience to develop complex strategies
• Ability to build and leverage expertise across the bread the of the Medtronic enterprise regulatory function(s)
• Experience in impactful negotiations with regulatory agencies
• Deep knowledge of pre- and post-market compliance requirements
• Experience partnering across functions on advertising and promotional activities
• Technical aptitude
• Background in a scientific or other technical discipline
• Excellent problem-solving skills and an ability to apply critical thinking
• Knowledge of product development processes and tools
• Application of significant working knowledge of other functional areas to identify and execute on opportunities for improvement
• Business acumen Significant experience as a member of senior business leadership teams
• Demonstrated ability to partner to resolve complex business challenges
• Ability to apply domain expertise and knowledge of regulatory environment to advise business on appropriate actions and future direction
• Influences across functions and businesses to negotiate and gain cooperation on divergent objectives.
• Competency in management of departmental budget
• Communication / Leadership Skills Demonstrated ability to develop and maintain strong, impactful relationships with global regulators
• Ability to clearly articulate a complex strategy
• Collaboration skills to partner with other functions to develop efficient approval strategies and resolve complex issues
• Confidence and impact in presenting to diverse audiences
• Ability to lead a team of experienced regulatory staff with responsibility for organizational structure and talent strategy ensuring skillsets evolve to meet the needs of the global regulatory landscape

Responsibilities

• Provide strategic regulatory guidance to business leadership.
• Develops and implements strategies to achieve timely global commercialization of products in compliance with applicable regulations and standards.
• Ensures comprehensive and compliant support of released products and support internal and external audits.
• Develops and maintains ongoing relationships with global regulatory partners and regulatory authorities.
• Establishes and maintains internal controls to ensure compliance as required by regulatory authorities.
• Partners across the business and enterprise to continually improve processes related to regulatory activities.
• Leads a strong, diverse regulatory affairs team with the competencies required to support a global portfolio in an evolving regulatory landscape.
• Establish clear performance metrics, develop team capabilities, and implement strategies to attract, retain, and grow top talent in quality and regulatory disciplines
• Demonstrate an ability to leverage learning and experience therapy-to-therapy in gaining approvals and maintaining approved status.
• Review advertising and promotional materials

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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 , and Simple Steps (global well-being program).
• 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) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level