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Manager, Regulatory Affairs (Tijuana)

Company: Merit Medical Systems Inc
Location: South Jordan
Posted on: September 13, 2020

Job Description:

Manager, Regulatory Affairs (Tijuana) #571-21646

South Jordan , UT

Working Hours

1st

Area of Interest

Regulatory Affairs

Job Description

SUMMARY OF DUTIES

Manages the day-to-day activities of the Regulatory Affairs department.

ESSENTIAL FUNCTIONS PERFORMED

Hires, evaluates and assigns work tasks to departmental employees.

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 problems.

Performs a variety of other functions related to representing Merit in dealings with regulatory agencies.

Lifting -- Not to exceed 50 lbs. -- local practice may apply.

Writing

Sitting

Standing

Bending

ยง Visual acuity

Color perception

Depth perception

Reading

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 preparation.

Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.

Supervisory process

Internal/external audit support

Regulation and law communication/training

FDA communication

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), and Nights

* Medical/Dental & Other Insurances (eligible the first of month after 30 days)

* No Cost Onsite Dental Clinic | Low Cost Onsite Medical Clinic

* 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 .

Keywords: Merit Medical Systems Inc, South Jordan , Manager, Regulatory Affairs (Tijuana), Other , South Jordan, Utah

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