Principal Regulatory Affairs Specialist
BASIC QUALIFICATIONS:
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
BASIC QUALIFICATIONS:
EDUCATION REQUIRED:
• Bachelor Degree in relevant field
YEARS OF EXPERIENCE
• 7+ years with Bachelor Degree medical device experience, and work experience in regulatory affairs.
• 5+years with Master’s Degree medical device experience, and work experience in regulatory affairs.
All with in-depth knowledge of U.S. and international regulations and firm understanding of key industry standards basic to medical device manufacturing.
SPECIALIZED KNOWLEDGE REQUIRED
• Experience in the preparation of 510(k) submissions, EU technical files and dossiers
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PREFERRED QUALIFICATIONS
• 10+ years with Bachelor Degree medical device experience, and work experience in regulatory affairs.
• 8+years with Master’s Degree medical device experience, and work experience in regulatory affairs.
• In-depth knowledge of U.S. and EU regulations and a working knowledge of key industry standards applicable to a medical device manufacturer, with functional understanding of international device regulations
• Direct experience in radiation health regulations
• Knowledge of Good Manufacturing Practices
• Excellent interpersonal skills
• Excellent oral and written communication skills.
• Basic office computer skills (email, word-processing and spreadsheet software)
• Good presentation skills
• Must be able to handle multiple tasks/projects and manage priorities accordingly
• Must have a high tolerance for ambiguity
• Must be able to independently identify and initiate tasks/projects in line with objectives
• Ability to provide guidance to lower level personnel without alienation.
• Regularly addresses complex problem with ingenuity and innovation.
• Ability to handle multiple tasks/projects and manage priorities accordingly.
• Ability to lead a team to completion of objectives.
• Successful track record in working on project teams in a matrix organization environment
• Experience in the preparation of PMA’s (pre-market approval) and IDE’s (Investigational Device Exemption) beneficial
• Understanding of diagnostic x-ray products and their respective regulations (21 CFR Subchapter J) preferred
• Knowledge of international quality and product standards for electro-medical equipment (e.g. ISO14971, ISO13485, EN60601, IEC62304, etc.) preferred
• Experience in establishing and implementing world-wide approval strategies for complex capital equipment systems preferred
• Experience in due-diligence evaluations of companies and/or product acquisitions preferred
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.
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.
EEO STATEMENT:
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
DISCLAIMER:
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.
