Senior Medical Safety Specialist

BASIC QUALIFICATIONS:

Bachelor of Science or Healthcare related and 10+ years’ experience

Advanced degree with 8+ years of experience

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DESIRED/PREFERRED QUALIFICATIONS:

·       5 years of relevant experience (pharmaceutical, medical device industry or clinical/clinical research experience).

•     Relevant work experience in cardiovascular diseases, cardiac devices, heart failure, cardiac surgery, ICU or clinical risk management.

•     At least 3 years’ experience working in vigilance/safety area concerning Class III Devices and/or pharmaceutical industry or in related fields such as clinical research, or medical affairs

·        Experience in clinical research or Medical Safety monitoring.

·        Experience with application of Risk Management to Medical devices Excellent critical and analytical thinking skills.

·        Knowledge of ISO standards and FDA regulations related to Quality Systems, Medical Devices, and Risk Management.

·        Proven analytical skills working with Medical Safety data.

·        Proven communication skills, including written and oral presentation of scientific data and research results.

·        Effective scientific writing skills.

·        Proficient computer skills with experience in Microsoft Office Word, PowerPoint, and Excel. Knowledge of basic statistical techniques

·        Project management experience.

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PHYSICAL JOB REQUIREMENTS:

·        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.

·        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.

ABOUT MEDTRONIC:

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 

We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. 

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.

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: http://www.uscis.gov/e-verify/employees

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.