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Job Description
Regulatory Coordinator responsible for ensuring global regulatory compliance for assigned product lines, coordinating recalls, and performing duties with limited input from management.
At Merit Medical, our mission is to create innovative medical devices that improve lives. We are a dynamic and collaborative environment that values every employee as an individual. With a diverse workforce of over 900 employees, we are proud of our energetic and dynamic culture.
Key Responsibilities:
- Determine global regulatory pathways for various projects, including product classification and type of regulatory submission or rationale required.
- Participate on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
- Identify guidance documents, international standards, Consensus Standards and assist teams with their interpretation.
- Prepare regulatory submissions to the FDA, the Notified Body and other regulatory authorities.
- Prepare IDEs and PMAs and assist with clinical trials when required.
- Interact with various levels of management, external agencies and companies.
- Analyze and make recommendations regarding field complaints.
- Develop, maintain and analyze department systems and provide training when needed.
- Remain current on developing regulations and revise systems as necessary.
- Participate in and assist with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
- Assist 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.
- 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 spreadsheets, word processing, database, internet research and other applicable software programs.
Benefits:
- Attractive salary package.
- Defined Contribution Pension Plan.
- Health Insurance Cover.
- Life assurance.
- Health & Wellbeing Events Calendar.
- Excellent career progression opportunities.
- Recognition scheme.
- Free Parking.
- Educational assistance.
- Internal training courses.
- Quality Subsidised Canteens & Barista Service.
- Active Sports and Social Club.