Sr Regulatory Affairs Manager
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
Bachelors Degree with 8+ years of regulatory affairs experience or experience in a related field and 3+ years of supervisory experience
Desired Qualifications:
• Demonstrated practical experience working directly with regulatory agencies, preferably including both FDA and European notified bodies
• Experience working on global regulatory submissions for combination products
• Good working knowledge of clinical trial design and data analysis
• Demonstrated knowledge of global medical device regulations & overall regulatory environment
• Track-record of improving regulatory or cross-functional business systems and processes
• Demonstrated supervisory and interpersonal skills
Thorough working knowledge of word processing, spreadsheet, and presentation applications (Microsoft Office, Adobe Acrobat). Organizational skills, attention to detail, and effective project management skills.
Flexible with changing priorities, self-motivated, strong work ethic, works well under pressure and thrives in a dynamic environment. Tactful, exercises independent judgment and discretion, professional presentation, advanced communications skills (written and oral), team player.
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.
