Sr Regulatory Affairs Specialist
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
BA and/or BS degree
YEARS OF EXPERIENCE:
Minimum of 4 years regulatory affairs or other relevant experience with
Bachelors
Minimum of 2 years regulatory affairs or other relevant experience with
Masters
Minimum of 0 year(s) regulatory affairs or other relevant experience with
Doctorate
DESIRED/PREFERRED QUALIFICATIONS
In depth experience with FDA requirements, guidance documents, 510(k)
submissions, Medical Device Directive, ISO 14971, ISO 13485, and other
global regulatory requirements and quality standards
History of successful device submissions
Knowledge of GLP/GCP requirements
Strong negotiation skills and written/oral communication skills
Strong organizational skills and time management skills
Ability to multitask, support multiple projects, function on a global basis,
prioritize, conduct team meetings, and meet project deadlines
Ablity to work independently and under general direction only
Computer skills; MS Office,, MS Project, Adobe Acrobat, Agile and Trackwise
PHYSICAL 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.
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.