Regulatory Operations Manager CRM

Regulatory Operations Manager

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.

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.

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.

This role is based in Mounds View, MN.

The Regulatory Operations Manager leads a team responsible for regulatory submission publishing, product lifecycle management, master data administration, change control support, audit readiness, and other regulatory activities. This role combines operational expertise with strategic leadership to drive efficiency, quality, compliance, and team development in global regulatory processes.

Key Responsibilities:

Team Leadership and Development:

• Prioritize strategic and departmental initiatives, define performance goals and objectives, conduct performance reviews, and hold regular 1:1s to guide employee development and performance management.
• Foster a culture of collaboration, accountability, and continuous improvement within the team.
• Collaborate with Regulatory peers within our function and across other Operating Units (OUs) to support and drive the successful implementation of new initiatives and ensure business continuity.

Regulatory Operations:

• Oversee the preparation, compilation, and publishing of regulatory submissions, including license renewals and annual registrations, ensuring compliance with global standards.
• Ensure accurate and efficient management of product lifecycle data and master data systems to support regulatory and business needs.
• Lead regulatory aspects of change control processes, ensuring timely and compliant implementation.
• Oversee planning of submission related post-market costs of the department budget; approve spending within defined limits.
• Represent Regulatory on Enterprise-wide initiatives, keeping senior management within our OU and those that we support informed of new developments and any issues.

Audit Support and Compliance:

• Support internal and external audits by ensuring documentation, processes, and systems are audit-ready and compliant with applicable regulations and standards.
• Maintain up-to-date knowledge of global regulatory requirements and ensure team activities align with those regulations, guidelines, and standards.

Process Optimization and Systems Management:

• Identify and implement process improvements to enhance efficiency and compliance in regulatory operations.
• Optimize the use of electronic systems, templates, and reporting capabilities to streamline operations and improve outcomes.

Training and Collaboration:

• Develop and support training programs to enhance team expertise in regulatory processes, tools, and systems.
• Collaborate with internal stakeholders and external vendors to ensure seamless operations and alignment on submission and compliance objectives.

Data Analysis and Reporting:

• Monitor and analyze data from diverse systems to support tracking, reporting, and decision-making related to regulatory operations, compliance initiatives, and process improvements.

Must Have; Minimum Requirements:

• Requires a Baccalaureate and minimum of 5 years business operations experience, or advanced degree with a minimum of 3 years business operations experience.

Nice To Have:

• Medical device industry experience.
• Knowledge of regulatory submissions, product lifecycle management, change control processes, and audit readiness.
• Proven leadership experience, with ability to mentor, develop, and manage teams.
• Analytical skills and proficiency in electronic document management systems and reporting tools.
• Excellent problem-solving, process improvement, and communication skills.

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): $120,800.00 - $181,200.00. 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

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. 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 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.