We anticipate the application window for this opening will close on - 18 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

As the Regulatory Affairs Strategic Planning Program Manager specializing in developing Globalization strategic implementation plan. You will be responsible for leading and managing multiple complex regulatory programs focused on expanding market access, maintaining access to current markets and ensuring compliance across international markets. Your role is critical in driving the execution of regulatory strategic plan, coordinating global submissions, and fostering cross-functional collaboration to achieve regulatory milestones efficiently. This position requires strong project management skills, regulatory expertise, and a strategic approach to navigating global regulatory landscapes. This role requires a proactive individual with exceptional organizational, analytical, and interpersonal skills who can manage multiple projects and priorities simultaneously.

Location: Hybrid working arrangement from Lafayette, CO (preferred) / Minnesota / Mansfield, MA

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

• Develops long-range objectives and strategic plans for corporation or major division by identifying internal and external strategic issues that could affect growth and profitability.

• Scans environment for business opportunities, maintains surveillance over market, and may perform financial analysis of acquisition candidates.

• Develops and monitors profitability, productivity, and growth targets.

• May prepare acquisition proposals, recommend financial and nonfinancial strategic objectives and alternatives, and implement and maintain strategic and operational plans.

• Plans and coordinates business reviews, resource allocations, organization structures, and financial analysis.

Key Responsibilities:

Regulatory Program Management:

• Lead and manage regulatory strategic plan for ACM programs and projects focused on global market expansion, maintenance and compliance, ensuring alignment with business objectives and timelines.

• Develop detailed strategic planning project plans, milestones, and timelines for regulatory activities across multiple international markets for ACM products, strategic alliance program and distribution partnership.

Global Regulatory Strategy Execution:

• Develop and implement a global regulatory strategic plan in collaboration with internal stakeholders, including Operations, Commercial teams, Regional Regulatory team, Regulatory design & Strategic Alliance team.

• Drive alignment on regulatory requirements, submissions, and approvals to support product registration and commercialization goals.

• Provide data-driven insights and recommendations to inform strategic decisions

Cross-Functional Collaboration:

• Collaborate closely with cross-functional teams to integrate regulatory considerations into product changes, renewal, expansion and commercialization strategies.

• Serve as a key liaison between regulatory affairs and other departments to ensure alignment on regulatory globalization execution and compliance activities.

• Foster a collaborative and high performing culture within the team

• Collaborate with internal and external stakeholders to ensure alignment and proper support for Regulatory

Regulatory Submissions and Compliance:

• Ensure compliance with global regulatory requirements and standards, monitoring changes and implementing necessary updates to strategic plan

• Track project progress, manage timelines, and report on project status

Risk Management and Mitigation:

• Conduct risk assessments and identify potential regulatory risks and challenges associated with globalization strategies.

• Develop and implement mitigation strategies to address regulatory risks and ensure proactive compliance.

Regulatory Intelligence and Best Practices:

• Stay informed about emerging regulatory trends, guidelines, and changes globally, providing strategic insights and recommendations to stakeholders.

• Implement best practices and processes for efficient global regulatory operations and continuous improvement.

• Identify areas for improvement and implement process optimization initiatives.

Reporting and Communication:

• Create and maintain regulatory strategic plans per class of trade

• Prepare and present regular updates, reports, and dashboards on regulatory program status, milestones, and key metrics to senior management and stakeholders.

• Facilitate communication and alignment on regulatory strategies, challenges, and opportunities across the organization.

• Manage monthly meetings with regional led markets

Required Knowledge and Experience:

• Bachelor's degree with 5+ years of experience in regulatory affairs

OR

• An advanced degree with 3+ years of experience in regulatory affairs

Nice to Have:

• 7+ years of experience in medical device regulatory affairs with roles displaying increasing responsibility

• 1+ year of experience in medical device regulatory affairs program management

• Strong project management skills with experience leading cross-functional teams and managing regulatory projects from inception to completion

• In-depth knowledge of global regulatory requirements (FDA, EMA, CFDA, PMDA, etc.) and regulatory affairs principles

• Excellent communication, organizational, and problem-solving skills with a proactive and results-oriented approach

• Ability to work effectively in a fast-paced environment, prioritize tasks, and manage multiple projects simultaneously

• Experience with regulatory submissions and approvals in international markets

• Proficiency in regulatory software applications, project management tools, and databases

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

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.

Salary ranges for U.S (excl. PR) locations (USD):$128,000.00 - $192,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).

The following benefits and additional compensation are available to all regular employees: 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).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

About Medtronic

We lead 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 90,000+ 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.

Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.