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 LifeSENIOR REGULATORY OPERATIONS SPECIALIST – (Lafayette, CO, or Mounds View, MN)Join a diverse team of innovators who bring their world view, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
The Senior Regulatory Operations Specialist position is part of the Acute Care & Monitoring (ACM) Regulatory Affairs Team supporting regulatory compliance processes. Primary responsibilities include leading process improvement and harmonization efforts by developing, implementing, and maintaining systems to capture key regulatory data and performance metrics, as well as streamlining product release.
The successful candidate will be instrumental in executing new and improved regulatory operations strategies and regulatory data management of ACM products. The individual will work across our entire portfolio of product data to include Global Item Change (GIC), EU Database on Medical Devices (Eudamed), and rest of world device data requirements. Additional duties include developing internal tools for data analysis.
Responsibilities may include the following and other duties may be assigned.
- Support Clearing Product Blocks and Product Release Activities
- Support processes and systems used to meet the data submittal requirements of FDA’s GUDID and other global UDI systems, as necessary.
- Solve and prevent issues with systems and processes within tight timelines.
- Drive functional collaboration to identify topics or trends that require escalation to functional senior leadership.
- Provide technical support to regulatory operations and regulatory affairs personnel that may include data coordination, project status, data review, tracking, regulatory metrics reporting, and providing summaries of regulatory intelligence reports to the regulatory team.
- Support enterprise-wide regulatory management systems, including system coordination, training others, developing implementation plans and providing input into system designs.
- Perform regulatory operations responsibilities independently with a minimal level of guidance and supervision.
- Assist in the monitoring and analysis of the impact of new or changing standards and regulations, and other changes that impact product regulation around the world.
- Lead and initiate special projects with minimal direction from manager including collecting/analyzing data and presenting results.
Must Have: Minimum Requirements
Bachelor’s degree with 4+ years’ of relevant experience, or advanced degree with 2+ years’ of relevant experience.
Nice to Have
- Advanced knowledge of word processing, spreadsheet, database, and graphics presentation applications (Microsoft Office, Smartsheet, Power BI, Documentum, SharePoint, Sitebuilder)
Project management skills
Proven ability to work globally
Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
Excellent written and oral communication skills
Ability to quickly learn new computer technology software packages with minimal training
Ability to work effectively within a matrix environment
Ability to multitask and prioritize while managing multiple projects and day-to-day responsibilities
Ability to influence cross-functional teams without formal authority
Motivated self-starter with the ability to perform independently or in teams in a fast-paced environment in response to business-critical assignments.
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 & CompensationMedtronic 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 MedtronicWe 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.
Skills Required
- Bachelor's degree with 4+ years' of relevant experience, or advanced degree with 2+ years' of relevant experience.
- Advanced knowledge of Microsoft Office applications
- Project management skills
Medtronic Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Medtronic and has not been reviewed or approved by Medtronic.
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Parental & Family Support — Paid leave for birthing and non-birthing parents is positioned as notably generous, with additional Family Care Leave available for a range of caregiving needs. Fertility, adoption, donor, and surrogacy support adds depth for different paths to family-building.
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Retirement Support — A 401(k) match and an employee stock purchase plan are presented as meaningful long-term savings tools. Scholarship and tuition programs further reinforce financial security beyond salary.
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Healthcare Strength — Medical, dental, and vision coverage is consistently described as a strong part of the total rewards package. Mental health resources, critical illness coverage, and wellness supports broaden the overall health offering.
Medtronic Insights
What We Do
Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.
