Sr Regulatory Affairs Specialist - ENT
• 4+ years of technical experience in the medical device industry with Bachelor’s Degree
• OR 2+ years of experience in the medical device industry with Master’s Degree
• 2+ years of experience in the preparation of 510(k) submissions for FDA or Technical Files for EU.
• Advanced degree in a scientific discipline (regulatory affairs, engineering, physical/biological or health sciences).
• Effective interpersonal skills
• Effective team member
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities.
• Proficient computer skills
• Experience with Class II/III medical devices (510(k), PMA, IDE)
• Experience performing advertising and promotion reviews for medical devices
• Medtronic product development experience
• Clinical or statistical experience
• Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
• Project management skills
• Regulatory Affairs Certification
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%)
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
SPECIALTY THERAPIES offer a broad portfolio that addresses conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.
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.
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.