Senior Regulatory Affairs Specialist

Merit Medical Systems, Inc.

3d•Onsite

About The Position

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. Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.

Requirements

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.

Responsibilities

Determines 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 regulatory authorities.
Prepares IDEs and PMAs and assists with clinical trials when required.
Interacts with various levels of management, external agencies and companies.
Analyzes and makes recommendations regarding field complaints.
Develops, maintains and analyzes department systems and provides training when needed.
Remains current on developing regulations and revises systems as necessary.
Participates in and assists with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
Assists with supervision of department staff, as directed.
Performs other related duties and tasks, as required.