Regulatory Affairs Director
- Bachelor’s degree in Engineering, Regulatory Science, Life Sciences or related medical/scientific field
- 10 years’ experience in the medical device industry in a regulatory, clinical, R&D or quality function
- 5 years’ experience in regulatory affairs
- 7 years people management experience
- Proven experience with electromechanical medical device regulatory requirements and submissions, including software
- Exhibits comprehensive expertise in global regulations regarding the manufacture and distribution of medical devices and/or combination products.
- Proven experience with developing robust global clinical and regulatory strategies supporting the commercialization of high risk permanent implantable devices.
- Prior experience authoring and negotiating IDE, 510(k), Technical Files and Design Dossiers.
- Knowledge and experience with GCP, GLP and QSR.
- Expertise in pre-clinical studies, clinical trial design, project management, and negotiations with regulators.
- Ensures advertising and promotion of products conforms to the requirements of the specific market.
- Excellent oral and written communication skills.
- History of working collaboratively across functions.
- Proven ability to comprehend anatomy & physiology, principles of engineering and the practice of electrosurgery.
- Regulatory experience with robotic medical devices.
- Understanding of reimbursement requirements.
- Experience working cross-culturally.
- Ability to sit or stand for > 8 hours
- Keyboarding
- Ability to travel via automobile and airplane
- Close vision and 8+ hours computer time often required
- Ability to travel ~ 25% time.
In order to be considered for this position, the above basic
qualifications must be evident on your resume.
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.
