Clinical Safety Specialist

MDU Medtronic USA Inc; Minnesota; On-site; USD 85,000 - 127,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) with employer contribution and

Short-term disability

Paid time off

Job summary

Medtronic in Minnesota is seeking a Clinical Safety professional to support management of safety events and device deficiencies across clinical studies. You will review AEs/SAEs, collaborate with sites and study teams, and ensure regulatory compliance while coordinating safety reporting.

The role emphasizes on-site collaboration, cross-functional teamwork, and adherence to GCP guidelines, with a path to contribute to safety plans and audits.

Qualifications

• Bachelor’s degree required.
• 2+ years of safety experience.
• Previous Medtronic experience.
• Basic knowledge of GCP and regulatory guidelines for clinical trials.
• Fluent with medical terminology.

Responsibilities

• Review and assess adverse events, serious adverse events, device deficiencies, and potential complaints in clinical studies.
• Evaluate clinical study docs and CRFs to identify unreported safety events.
• Partner with sites, monitors, and study teams to obtain safety information.
• Coordinate safety reporting and ensure regulatory compliance.
• Support safety reports, clinical study reports, and sections of the investigation plan.

Skills

Safety events handling

Regulatory compliance knowledge

MS Office proficiency

Medical terminology fluency

Education

Bachelor's degree

RN/PA or allied health qualification (optional)

Tools

MS Office

Job description

We anticipate the application window for this opening will close on - 1 Oct 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 Medical Clinical Research Solutions (MCRS) Clinical Safety team supports the management and reporting of safety events, potential complaints, and device deficiencies across clinical studies. The team partners closely with Clinical Research, Regulatory Affairs, Data Management, Product Complaint Reporting, and study teams to ensure compliance with applicable regulatory requirements and internal quality standards throughout the clinical study lifecycle. 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.

Primary Responsibilities

• Review and assess adverse events (AEs), serious adverse events (SAEs), device deficiencies, and potential complaints reported during clinical studies.
• Evaluate clinical study documentation and case report forms to identify potential unreported safety events and complaint‑related information.
• Partner with investigational sites, clinical monitors, and study teams to obtain and evaluate safety information.
• Coordinate safety reporting activities and ensure compliance with clinical investigation plans, regulatory requirements, and internal procedures.
• Author and maintain Clinical Safety Management and Potential Complaint Plans for assigned studies.
• Support the preparation of safety reports, clinical study reports, annual reports, and clinical investigation plan safety sections.
• Collaborate with Regulatory Affairs, Data Management, Product Complaint Reporting, and other stakeholders to ensure consistent safety event assessment and documentation.
• Support safety audits, database snapshot activities, safety trending reviews, and Clinical Event Committee processes.

Minimum Requirements

• Bachelor’s degree
• 2+ years of safety experience
• Previous Medtronic experience
• Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
• Fluent with medical terminology

Nice to Have

• Good written, oral, and interpersonal communication skills including knowledge of medical terminology.
• Proficient with MS Office products, word processing, spreadsheets, etc.
• High attention to detail and accuracy and ability to manage multiple tasks.
• Good prioritization and organizational skills.
• Excellent problem solving skills.
• Flexible and dependable.
• Works effectively on cross‑functional teams.
• RN, PA or allied health professional including Biomedical Engineer, Biomedical Scientist, will work on Cardiac device trials Coordinator 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):$84,800.00 - $127,200.00

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
• 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)
• 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.

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.

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.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here.