Clinical Safety Specialist
$84.8k - $127.2kMedtronic Inc
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 95000 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 -person exchanges are invaluable to our work. Were 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.
As a Clinical Safety Specialist you will support the assessment management and reporting of clinical study safety events and potential complaints. You will collaborate with cross-functional partners to ensure timely safety reporting maintain compliance with clinical and regulatory requirements and support safety oversight activities across clinical studies.
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:
- Bachelors 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 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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.
If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .
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.
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:
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 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.
Required Experience:
IC
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