Regulatory Operations Specialist (Finance)

We anticipate the application window for this opening will close on - 28 May 2025

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

Position is open to remote in the US or Bogota, Colombia.

This role is part of the Medtronic Clinical & Regulatory Solutions (MCRS) organization, focusing on enhancing regulatory systems and processes. Key responsibilities include collaborating with the Registration and Listing Value Stream team to manage daily operations related to FDA Establishment Registrations, Device Listings, annual registration, and internal and external audits. This position also manages the Owner/Operator (O/O) account and provides guidance to Official Correspondents (OC), US Agents, and OU Regulatory teams. Additionally, there are opportunities to contribute to the Unique Device Identification (UDI) system and teams, ensuring data integrity within regulated systems like the Global Unique Device Identification Database (GUDID).

Key Responsibilities:
• Act as the primary point of contact for registration and listing, ensuring effective communication with internal stakeholders.
• Collaborate with Owner/Operators (O/O), Official Correspondents (OCs) both within and outside the U.S., and U.S. Agents to manage FURLS accounts.
• Work closely with Official Correspondents and Operating Unit (OU) Regulatory teams to manage registrations and listings, ensuring all processes are compliant with FDA regulations.
• Oversee the annual registration processes, including establishment renewals and device listings data integrity reviews, ensuring timely completion and compliance with FDA regulations.
• Maintain and archive documentation of FURLS DRLM establishment registrations and listings data to demonstrate compliance and accuracy.

A role in MCRS offers unique experience opportunities, such as: being part of a global team, collaborating with business partners throughout the company, visibility to global structures and impacts, and insight to various processes and functions across Medtronic.

• Maintain FDA Device Establishment Registration and Device Listings, ensuring accuracy and compliance.
• Provide daily support for regulatory systems and projects, contributing to efficient operations.
• Interface with various teams to address queries and resolve issues, fostering effective communication and collaboration.
• Support audits and inspections, offering consultation to OU Regulatory Affairs teams and other stakeholders.
• Conduct training sessions for various stakeholders, including Official Correspondents, U.S. Agents, OU Regulatory Affairs, and other cross-functional teams.
• Participate in initiatives focused on improving regulatory processes and systems, identifying and implementing metrics to enhance business efficiencies.

Must Have: Minimum Requirements:
• Bachelor's degree with at least 2 years of relevant experience.
• Strong understanding of FDA regulations related to medical device registration and listing.

Nice to Have:
• Experience with the Device Registration and Listing Module (DRLM) in FURLS and direct interaction with the FDA.
• Proven ability to effectively collaborate with upper leadership, including Manager, Sr Manager, and Director levels.
• High degree of initiative and ability to perform well under pressure in a dynamic environment.
• Experience in submitting expense reports and managing responsibilities for a purchase card.
• Advanced proficiency in Microsoft Office, Adobe Acrobat, Documentum, SharePoint, and Sitebuilder.
• Strong organizational skills, attention to detail, and effective project management capabilities.
• Excellent interpersonal and communication skills, both written and oral.
• Flexibility with changing priorities, self-motivation, strong work ethic, and professionalism.
• Ability to exercise independent judgment and discretion, with a professional presentation and team player attitude.
• Understanding of Unique Device Identification (UDI) requirements.

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):$74,400.00 - $111,600.00

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

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.