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**SUMMARY OF DUTIES**
This position is responsible for coordinating and preparing regulatory submissions on a global level for the United States, Europe and other international countries. Other responsibilities include coordinating recalls, assisting with FDA facility inspections, Notified Body audits, and assisting with MDR, MPR, or Vigilance report recommendations.
**ESSENTIAL FUNCTIONS PERFORMED**
- Assist with determining global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
- Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
- Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
- Prepares regulatory submissions to the FDA, the Notified Body and other Ministries of Health.
- Interacts with various levels of management, external agencies and companies.
- Assist with analysis and making recommendations regarding complaints received by Merit Medical and whether they are MDR, MPR, or Vigilance reportable; participates in complaint related meetings.
- Assist with developing, maintaining and analyzing department systems and provides training when needed.
- Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed.
- Performs other related duties and tasks, as required.
**SUMMARY OF MINIMUM QUALIFICATIONS**
- Education and/or experience equivalent to a bachelor's degree in the biological, physical, engineering or material science disciplines and four years of related experience.
- Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and ISO 13485 Quality System Standards.
- Supervisory skills are preferred.
- 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
- Assistance with medical device and vigilance reporting
- Computer skills/internet research
- Interpersonal/communication skills
- Assistance with regulatory system development/training
MERIT MEDICAL SYSTEMS, INC.
EQUAL OPPORTUNITY EMPLOYER M/F/D/V
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