Principal Clinical Quality Specialist
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IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
BASIC QUALIFICATIONS:
EDUCATION REQUIRED:
• Bachelor’s degree
YEARS OF EXPERIENCE
• 7+ years of experience (or 5+ years with a Master’s degree) directly supporting clinical research within a regulated environment, quality experience in a regulated environment.
SPECIALIZED KNOWLEDGE REQUIRED
• Experience with FDA and international regulations (pharmaceutical and/or device, e.g., 21 CFR 812, 11, 50, 54, 56, 803, 806, 820, ISO 13485, ISO 14155, EU MDR, MedDev)
DESIRED/PREFERRED QUALIFICATIONS:
• Knowledge of ISO 14971, AIMDD, MDD, CMDCAS/ CMDR, JPAL and other international regulatory agency requirements.
• Proficient computer skills and demonstrated competence to include word-processing, database applications, and spreadsheet in a network environment.
• Demonstration of self-motivation and leadership skills.
• Capable of performing work remotely.
• Excellent written and oral communication skills and ability to interface professionally and diplomatically throughout all levels of the organization.
• Ability to work with international teams.
• Ability to manage time efficiently and multi-task.
• Ability to prioritize tasks using a risk based approach.
• High attention to detail and accuracy
• Able to manage complex tasks
• Strong interpersonal skills, ability to work with teams and be a self-initiator
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.
• Ability to travel up to 30%
MEDTRONIC OVERVIEW:
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.
