Senior Regulatory Affairs Specialist

MedStar Health; Utah; On-site; USD 70,000 - 100,000; Full time

Job summary

A leading medical devices company in Utah is seeking a Regulatory Specialist to manage and prepare regulatory submissions to the FDA and other regulatory bodies. The ideal candidate will have a Bachelor's degree in a technical field and at least six years of industry experience, demonstrating a strong understanding of U.S. and international regulations. The role involves defining regulatory requirements, participating in audits, and providing training. Benefits include comprehensive health insurance, vacation time, and a supportive environment for career growth.

Benefits

Medical/Dental & Other Insurances

Low Cost Onsite Medical Clinic

Three Weeks' Vacation

401K & Health Savings Account

Employee Garden & Gardening Classes

Qualifications

• Minimum 6 years related industry experience.
• Knowledge of U.S. FDA regulations and ISO 13485.
• Experience with authoring regulatory submissions.

Responsibilities

• Determine global regulatory pathways for projects.
• Prepare regulatory submissions to the FDA and other authorities.
• Assist with supervision of department staff.

Skills

Regulatory submission preparation

Communication skills

Attention to detail

Time management

Computer skills

Education

Bachelor's Degree in a technical field

Job description

Work Shift:

DAY

Work Schedule:

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. Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
2. Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
3. Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
4. Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities.
5. Prepares IDEs and PMAs and assists with clinical trials when required.
6. Interacts with various levels of management, external agencies and companies.
7. Analyzes and makes recommendations regarding field complaints.
8. Develops, maintains and analyzes department systems and provides training when needed.
9. Remains current on developing regulations and revises systems as necessary.
10. Participates in and assists with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
11. Assists with supervision of department staff, as directed.
12. Performs other related 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

SUMMARY OF MINIMUM QUALIFICATIONS

* Education and/or experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience.
* Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
* Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
* 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.
* Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.

COMPETENCIES

* Regulatory submission/rationale preparation
* Global Regulatory paths/strategies
* Computer skills/internet research
* Interpersonal/communication skills
* Regulatory system development/training
* Field Action coordination and reporting
* Product development and change qualification processes

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.