Manager, Regulatory Affairs (Tijuana) #571-21646
South Jordan , UT
Area of Interest
SUMMARY OF DUTIES
Manages the day-to-day activities of the Regulatory Affairs
ESSENTIAL FUNCTIONS PERFORMED
Hires, evaluates and assigns work tasks to departmental
May manage audits from outside regulatory agencies.
Ensures that Merit is aware of domestic and international laws
and regulations that govern regulated medical products.
Informs staff personnel and other Merit employees of regulations
and laws that pertain to their respective responsibilities and that
relate to the legal manufacture and sale of medical devices,
including anticipated changes in regulations or in the
interpretation of the law by regulatory agencies.
Works with other staff in resolving regulatory and technical
Performs a variety of other functions related to representing
Merit in dealings with regulatory agencies.
Lifting -- Not to exceed 50 lbs. -- local practice may
§ Visual acuity
Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS
Education and/or experience equivalent to a Bachelor's Degree in
a technical field such as in the biological, physical, engineering
or material science disciplines.
A minimum of seven years regulatory experience, with three of
those years in a supervisory capacity.
Demonstrated knowledge of U.S. FDA regulations, the Medical
Devices Directive (93/42/EEC), ISO 13485 Quality System Standard
and Canadian Medical Device Regulation.
Self-motivated, self-directing, strong attention to detail and
excellent time management skills.
Strong interpersonal skills and the ability to communicate well
-- verbally and in writing -- with others.
Excellent leadership skills and the ability to work well with
people at all levels of the organization.
Excellent analytical and problem solving skills.
Demonstrated excellence in submission writing and
Demonstrated computer skills preferably spreadsheets, word
processing, database and other applicable software programs.
Internal/external audit support
Regulation and law communication/training
Regulatory and technical problem solving
International medical device regulations
Field Action coordination and reporting
Product development and change qualification processes
Infectious Control Risk Category III:
The risk category explains whether or not employees are likely
to come into contact with blood or body fluids while performing
their jobs. Risk category III states employment and procedures that
do not require exposure.
At Merit Medical, our mission is to create innovative medical
devices that improve lives. Our goal is to hire and develop people
who want to build something special through hard work, team effort,
and commitment. Together, we are making a difference in the lives
of patients around the world.
As an eligible Merit employee, you can expect the following:
* Multiple Shifts and Hours to choose from: Days, Swing (Eve),
* Medical/Dental & Other Insurances (eligible the first of month
after 30 days)
* No Cost Onsite Dental Clinic | Low Cost Onsite Medical
* Two (2) Onsite Cafeterias
* Employee Garden | Gardening Classes
* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
* 401K | Health Savings Account
To see more on our culture, go to www.merit.com/careers .