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Job Description
Regulatory Coordinator needed to ensure compliance for assigned product lines globally.
At Merit Medical, our mission is to create innovative medical devices that improve lives. We strive to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we make a difference in the lives of patients around the world.
Key Responsibilities
- Determines global regulatory pathways for various projects, including product classification and regulatory submission requirements.
- Participates in teams to define regulatory requirements for U.S. and international submissions, technical files, or regulatory rationales.
- Identifies guidance documents, international standards, and assists teams with their interpretation.
- Prepares regulatory submissions to the FDA, 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.
- Analyses and makes recommendations regarding field complaints.
- Develops, maintains, and analyses 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.
Requirements
- Equivalent to a Bachelor's Degree in a technical field such as biology, physics, engineering, or material science.
- At least six years of related industry experience.
- Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), the Medical Devices Regulation (2017/745), and various Quality System Standards/Regulations/Laws.
- 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 in spreadsheets, word processing, database, internet research, and other applicable software programs.
About Us
Merit Medical Galway, established in 1993, has grown from 22 employees to over 900 employees worldwide. We are a global leader in the medical industry, with a diverse, multi-campus manufacturing footprint in Europe, North America, South America, Asia, and Australia.