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About the Role

In this role as the Principal Clinical Research Specialist (CRS) within the Cardiac Ablation Solutions (CAS) Operating Unit, you will lead the development and execution of global clinical and regulatory strategies to support innovative ablation therapies and timely worldwide product approvals. You will drive clinical evidence generation, oversee complex clinical studies, and ensure compliance with regulatory requirements, ethical principles, and Good Clinical Practice (GCP). This role develops strategies and drives processes to achieve key clinical and regulatory milestones, ensuring study data, submissions, and deliverables are comprehensive, accurate, and aligned with Medtronic business objectives. You will collaborate with cross-functional stakeholders and build relationships with internal and external stakeholders, including investigators, key opinion leaders, regulatory authorities, and senior leaders, while managing the successful execution of clinical programs and strategic deliverables. Individuals supporting a specific region or country may also serve as a clinical research representative to local customers, investigators, and regulatory authorities, informing product development, evidence generation, and regulatory strategies. This role has high visibility to senior leaders at Medtronic.

Responsibilities

Lead the development and execution of global clinical and regulatory strategies that support the advancement of innovative ablation therapies and timely worldwide product approvals.
Drive clinical evidence generation.
Oversee the design and execution of complex clinical studies.
Ensure compliance with applicable regulatory requirements, ethical principles, and Good Clinical Practice (GCP).
Develop strategies and drive processes to achieve key clinical and regulatory milestones.
Ensure that study data, submissions, and deliverables are comprehensive, accurate, and aligned with Medtronic business objectives.
Collaborate with members of the CAS leadership team and cross-functional stakeholders (e.g., Research and Development, Regulatory Affairs, Medical Affairs, Clinical Operations, Clinical Evidence, Biostats, Quality, Marketing, and other business partners).
Build relationships and communicate effectively with a broad range of internal and external stakeholders including investigators, key opinion leaders, regulatory authorities, and senior leaders.
Manage the successful execution of clinical programs and the timely completion of strategic deliverables.
Serve as a clinical research representative to local customers, investigators, and regulatory authorities (for regional/country roles).
Inform product development, evidence generation, and regulatory strategies.
Be independently mobile.
Interact with a computer.
Communicate with peers and co-workers.

Requirements

Bachelor's degree
Minimum of 7 years of clinical research experience
Or Advanced degree with 5 years of clinical research experience
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Reside within the territory.
Drive to multiple accounts throughout the region.
Possess a valid driver's license.

Skills

Strong knowledge of electrophysiology, cardiac mapping, and catheter ablation technologies.
Experience working with key opinion leaders, preferably cardiac electrophysiologists.
Experience leading clinical studies and overseeing clinical trial data review, analysis and interpretation.
Clinical Research experience at Medtronic or within the medical device industry, preferably in cardiovascular or electrophysiology therapies.
Strong knowledge of clinical research methodologies, including study design, implementation, data analysis, evidence generation, and reporting.
Experience with Clinical Operations.
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
Experience supporting regulatory submissions and interactions with global regulatory authorities.
Demonstrated ability to develop and execute clinical evidence strategies that support product development, regulatory, and business objectives.
Excellent project management, organization, and stakeholder management skills.
Strong written and verbal communication skills, with the ability to influence and collaborate across functions and organizational levels.

Location

Remote
Must reside within the territory

Work Type

Remote
Full-time

Experience Level

Principal

Education Level

Bachelor's degree
Advanced degree

Salary/Compensations

$144,800.00 - $217,200.00
Eligible for Medtronic Incentive Plan (MIP)

Benefits

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
Simple Steps (global well-being program)
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
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

About the Company

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life.
Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.
Cardiac Ablation Solutions (CAS) offers innovative cardiac mapping and ablation technologies designed to treat patients with abnormal heart rhythms (arrhythmias).
CAS focuses on advancing the field with cutting-edge ablation catheters, cardiac mapping systems, and traditional electrophysiology (EP) products.
CAS operates within Electrophysiology Therapies Operating Unit and addresses the growing challenges healthcare professionals face, such as increasing patient volumes, complex arrhythmias, and resource constraints.
Medtronic’s versatile, cost-effective cardiac ablation solutions help reduce the financial burden on healthcare systems while delivering effective treatments.
Medtronic’s CAS portfolio includes a variety of catheters designed to deliver cryoablation, radiofrequency ablation, and pulsed field ablation energies.
Our solutions are tailored to treat a wide range of arrhythmias, offering single shot, wide area focal, and focal capabilities, to ensure the best possible outcomes for patients.

Equal Opportunity

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.
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.