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Job Description
Job Summary: Regulatory Coordinator responsible for ensuring global regulatory compliance for assigned product lines, coordinating recalls, and identifying relevant standards and guidance documents.
At Merit Medical, our mission is to create innovative medical devices that improve lives. We are a global company with a diverse workforce and a strong commitment to people development and diversity and inclusion.
As a Regulatory Coordinator, you will play a key role in ensuring the company's products meet regulatory requirements in Europe, the United States, and other countries. Your responsibilities will include:
- Determining global regulatory pathways for various projects, including product classification and type of regulatory submission or rationale required.
- Participating on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
- Identifying guidance documents, international standards, Consensus Standards and assisting teams with their interpretation.
- Preparing regulatory submissions to the FDA, the Notified Body and other regulatory authorities.
- Preparing IDEs and PMAs and assisting with clinical trials when required.
- Interacting with various levels of management, external agencies and companies.
- Analysing and making recommendations regarding field complaints.
- Developing, maintaining and analysing department systems and providing training when needed.
- Remains current on developing regulations and revises systems as necessary.
- Participating in and assisting with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
- Assists with supervision of department staff, as directed.
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), the Medical Devices Regulation (2017/745) 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.
About Merit Medical:
- We are a global company with a diverse workforce and a strong commitment to people development and diversity and inclusion.
- We are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are excelling in the Med Tech industry.
- We value every employee as an individual and offer a supportive and collaborative environment.