Senior Clinical Research Specialist

Regulatory Jobs; Fridley (MN); Hybrid; USD 106.000 - 158.000; Vollzeit

Benefits dieser Stelle

Flexible onsite work model

Zusammenfassung

Medtronic is seeking a Senior Clinical Research Specialist to lead development of clinical, scientific, and regulatory documentation, supporting regulatory submissions and evidence generation for neurovascular therapies.

The role requires a Bachelor's degree in a technical field with 4+ years of clinical research or regulatory writing, and involves collaboration across Clinical, Regulatory, Quality, Marketing, and cross-functional teams in a hybrid onsite model with up to ~25% travel.

Qualifikationen

• Bachelor’s degree in a technical discipline with 4+ years of relevant clinical research or regulatory writing experience.
• Experience authoring clinical, scientific, or regulatory documentation for regulated healthcare products.
• Experience collaborating with cross-functional teams in a regulated medical device environment.
• Ability to analyze and communicate clinical data to diverse stakeholders.

Aufgaben

• Author and lead clinical, scientific, and regulatory documents such as protocols, study reports, and regulatory submissions.
• Develop evidence strategies aligned with program objectives and regulatory requirements.
• Collaborate with Clinical, Research & Development, Regulatory, Quality, Marketing, and Health Economics teams.
• Summarize and present clinical data through reports, presentations, and evidence summaries.

Kenntnisse

Clinical research

Regulatory writing

Medical device experience

Scientific writing

Cross-functional collaboration

Ausbildung

Bachelor's degree in technical discipline

Advanced degree

Jobbeschreibung

We anticipate the application window for this opening will close on - 9 Nov 2026

Careers that change lives start here. 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. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Neurovascular Clinical Research team supports the global clinical development of therapies designed to treat stroke and other neurovascular conditions. This team partners across Clinical, Research & Development, Regulatory, Quality, Health Economics & Reimbursement, Marketing, and Medical Affairs to generate clinical evidence that supports product development, regulatory submissions, and commercialization activities.

Primary preference is for candidates based in Fridley/Mounds View, Minnesota OR Irvine, California OR Lafayette, Colorado. This role follows a flexible onsite work model with a minimum of four days per week onsite. Travel requirements are expected to be ~25% based on business needs.

Check us out on LinkedIn: Medtronic Neurovascular

The Senior Clinical Research Specialist supports clinical development programs by leading the development of clinical, scientific, and regulatory documentation while partnering with cross-functional stakeholders to advance evidence generation strategies. This role contributes to study start-up, study execution, publication planning, regulatory submissions, and broader clinical development initiatives supporting neurovascular therapies.

Primary Responsibilities

• Author and lead the development of clinical, scientific, and regulatory documents, including clinical study protocols, clinical study reports, clinical evaluation reports, annual reports, risk-benefit assessments, and associated submission materials.


• Develop clinical evidence strategies and support clinical development activities aligned with program objectives and regulatory requirements.


• Partner with cross-functional stakeholders across Clinical, Research & Development, Regulatory Affairs, Quality, Marketing, Sales, Compliance, and Health Economics & Reimbursement to support product development and lifecycle initiatives.


• Interpret, analyze, and communicate clinical data through clear and scientifically accurate reports, presentations, and evidence summaries for internal and external audiences.


• Conduct scientific literature reviews, clinical evidence assessments, and literature database management activities to support development and regulatory objectives.


• Lead publication planning and execution activities in collaboration with physician investigators, key opinion leaders, and internal stakeholders.


• Monitor and summarize emerging scientific literature, conference presentations, and competitive developments relevant to the neurovascular therapeutic area.


• Manage multiple clinical and business-critical projects simultaneously, coordinating document reviews, stakeholder feedback, revisions, and approval processes.

Required Qualifications

• Bachelor’s degree in a technical discipline and 4+ years of relevant clinical research, scientific writing, regulatory writing, or medical device experience; or an advanced degree and 2+ years of relevant experience.


• Experience authoring or contributing to clinical, scientific, or regulatory documentation.


• Experience supporting cross-functional projects within a regulated healthcare, life sciences, or medical device environment.


• Ability to analyze, interpret, and communicate clinical or scientific data to diverse stakeholders.

Preferred Qualifications

• MD or PhD in a biomedical science discipline.


• Experience supporting clinical trials and clinical development programs within the medical device industry.


• Experience with clinical, medical, scientific, or regulatory writing and publication development.


• Neurovascular, stroke, vascular intervention, or related medical device therapeutic area experience.


• Experience supporting regulatory submissions and responses to health authorities.

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.

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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):$105,600.00 - $158,400.00

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, andSimple 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), andCapital 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. ("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.