Sr Regulatory Affairs Specialist

BASIC QUALIFICATIONS:

EDUCATION REQUIRED: 

• 4+ years with Bachelor's degree, medical device experience, and work experience in regulatory affairs.
• 2+ years with Master's degree, medical device experience, and work experience in regulatory affairs.

SPECIALIZED KNOWLEDGE REQUIRED:   

• Experience in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU.

• Bachelors degree  in science, engineering, healthcare or related field.
• 7+ years with Bachelors Degree, medical device experience, and work experience in regulatory affairs.
• 5+ years with Masters Degree, medical device experience, and work experience in regulatory affairs.
• In-depth knowledge of U.S. and EU regulations and a firm awareness of key industry standards basic to a medical device manufacturer, with functional understanding of international device regulations.
• Understanding of medical electrical equipment and their respective regulations.
• Understanding of combination products and their respective regulations.
• Experience in due-diligence evaluations of companies and/or product acquisitions preferred.
• Knowledge of drug regulations and GMP’s would be beneficial.
• Excellent interpersonal skills.
• Excellent oral and written communication skills.
• Basic office computer skills (email, word-processing and spreadsheet software).
• Effective Cross-functional team player.
• Good presentation skills.
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Must have a high tolerance for ambiguity.

PHYSICAL JOB REQUIREMENTS: Physical capabilities to perform the job

• 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 use a computer, and communicate with peers and co-workers.
• The employee must frequently lift and/or move up to 10 pounds. 

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.

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.