Senior Regulatory Affairs Program Manager
Medtronic.com
Office
CO Lafayette Bldg 1, United States
Full Time
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 a Senior Regulatory Affairs Program Manager, you will be the strategic linchpin that drives operational excellence across the different arms of the RA function within the Acute Care & Monitoring (ACM) operating unit. Your day will be a dynamic mix of strategic planning and tactical execution. A significant portion of your day will involve facilitating program-level meetings with leadership, where you will use your expertise to guide strategic discussions, manage through risks, and drive critical decisions to ensure the functional commitments are met. You will also dedicate time to analyzing and interpreting complex performance data, balancing resource demand across the function, managing the budget forecast relative to AOP, and driving process/systems improvement initiatives. Your role is a blend of a forward-thinking strategist, a hands-on problem-solver, and a collaborative leader, all working to ensure our regulatory affairs function operates at the highest level of efficiency and effectiveness.Responsibilities May Include
- Operating Mechanisms:
- Design, implement, and maintain advanced operating mechanisms to ensure seamless program execution and cross-functional alignment across all Regulatory Affairs programs.
- Establish and facilitate program-level meetings with senior leadership and key stakeholders to track progress, manage complex risks, and drive critical business decisions.
- Develop and manage comprehensive program calendars, communication plans, and high level stakeholder engagement strategies.
- Budget Management:
- Develop and manage the functional budget, including long-term forecasting, tracking, and reporting on expenditures.
- Ensure the optimal allocation of financial resources to support critical program objectives and key initiatives.
- Identify and implement significant cost reallocation opportunities without compromising quality or compliance.
- Process Improvement Initiatives:
- Lead and champion large-scale, high-impact process improvement initiatives aimed at enhancing the efficiency, quality, and effectiveness of regulatory operations.
- Resource Management:
- Collaborate with RA leaders and other department heads to forecast long-term resource needs and ensure appropriate staffing levels for all programs.
- Proactively identify and address complex resource constraints or conflicts to maintain project timelines and deliverable quality.
- Optimize resource utilization across a portfolio of multiple projects and initiatives.
- Performance Metrics Development and Execution:
- Develop, define, and implement key performance indicators (KPIs) and other sophisticated metrics to measure the success and efficiency of regulatory programs.
- Establish high level dashboards and reporting mechanisms to provide senior stakeholders with clear visibility into performance.
- Analyze complex performance data to identify strategic trends, opportunities for improvement, and areas of risk.
- Integration of Enterprise Initiatives:
- Act as the primary liaison between the RA function and enterprise-level program initiatives.
- Ensure the seamless integration of enterprise-level initiatives (e.g., new technology platforms, corporate compliance programs) into the ACM RA function.
- Communicate enterprise-level changes to the team and manage the associated change management activities.
- Other Business Initiatives:
- Provide expert program management leadership for ad-hoc projects, special assignments, and new ventures.
Differentiating Factors
- Experience with large-scale, enterprise-level initiatives: A background in integrating entire business units into broader corporate programs.
- Subject Matter Expertise: Deep knowledge of specific regulatory domains (e.g., global submissions, post-market surveillance, quality systems). Experience implementing initiatives through effective influence management skills at multiple levels in the organization with a general understanding of medical device regulations and submissions.
- Technical Proficiency: Experience with regulatory information management systems (RIMS), project management software (e.g., Smartsheet, MS Project), and data visualization tools (e.g., MS Excel, Power BI).
- Change Management: Demonstrated ability to lead and manage large-scale organizational change effectively.
Program Management Career Stream
This role is a key position within the program management career stream, offering significant growth opportunities. Successful performance in this role can lead to senior portfolio management positions or executive leadership roles within Regulatory Operations or other business functions. The ideal candidate will be a strategic and visionary thinker with a proven track record of driving complex, enterprise-level initiatives to successful completion, and a desire to continuously elevate their skills and responsibilities.
Minimum Requirements:
Bachelor's degree and 7+ years of regulatory program management experience, or advanced degree with 5 + years of regulatory program management experience.
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.
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
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 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.
Learn more about our business, mission, and our commitment to diversity here.
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.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.