Regulatory Affairs Specialist I

Work Shift:

DAY

Why Merit?

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.

ESSENTIAL FUNCTIONS PERFORMED

1.    Exemplify an engaged culture that is tied to the Merit Way and the RA Manifesto.
2.    Collaborate with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.
3.    Develop and maintain strong strategic partnerships with project team members, including Marketing, R&D, Operations, Clinical Affairs and Quality Assurance.
4.    Ensure all regulatory activities for assigned platform and operations projects comply with evolving global regulatory requirements.
5.    Maintain product knowledge within the team and ensure essential data is gathered and organized in support of global submissions.
6.    Partner with the Regional RA team in the development, alignment and execution of Regulatory strategies for platform and operations projects and changes, upholding rigorous standards of accuracy, timeliness, compliance and excellence in regulatory strategy.
7.    In collaboration with Regional RA, represent Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility.
8.    Support and suggest continuous improvement of regulatory processes, procedures and policies.
9.    Ensure compliance with relevant regulatory requirements.
10.    Ensure project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.
11.    Ensure the timely maintenance of regulatory data with a high degree of accuracy and compliance.
12.    Support Regulatory Affairs in due diligence activities to ensure regulatory risks and integration needs are clearly articulated and understood. Coordinate with Regional RA on the integration of new acquisitions.
13.    Support and when needed represent Regulatory Affairs in audits/inspections leading to successful outcomes.
14.    Performs other duties and tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

•    Lifting -- Not to exceed 50 lbs. -- local practice may apply.
•    Writing
•    Sitting
•    Standing
•    Bending
•    Visual acuity
•    Color perception
•    Depth perception
•    Reading
•    Field of vision/peripheral

MINIMUM QUALIFICATIONS

•    Bachelor's degree in life sciences, engineering, regulatory affairs or a related discipline.
•    General knowledge of global medical device regulations.
•    Relevant regulatory certifications (e.g., RAC) strongly preferred.

COMPETENCIES

•    Written and Verbal Communication
•    Attention to Detail
•    Continuous Improvement
•    Analytical Skills
•    Teamwork
•    Integrity
•    Organization

COMMENTS

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.
 

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)

* 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.

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.