Role: Project / Regulatory Specialist (Medical Devices) - Active
Location: Dublin, Ireland
Salary: Highly Completive
Russell Taylor Group has a fantastic opportunity for a Project / Regulatory Specialist (Medical Devices - Active) Due to our ongoing growth and success, we are searching for an experienced Certification Specialist who will join our leading Medical Team and be responsible for supporting our clients through the regulatory process for bringing medical devices to market. Working in conjunction with our customers you will independently plan and carry out complex and high-level (often of a highly confidential nature) projects to achieve company objectives.
- Performs needs analyses to identify areas for study or opportunities for new programs.
- Develops project or program goals and strategies.
- Determines methodology and development plans. Develops estimates of cost, time, and resource needs.
- Collects data from a variety of sources, evaluates and interprets data, and draws conclusions.
- Prepares and presents reports or program proposals which include recommendations and supporting arguments.
- Develops and implements processes, information systems, and performance measurement systems. Manages program performance by evaluating performance to standards and implementing corrective actions.
- Serves on committees and represents the viewpoint of management.
- May supervise the work of other individuals within department or functional area.
- Have a strong customer focus, flexibility.
- Familiar with product certification, concepts, medical devices, regulatory affairs, internal auditing and quality management
- Proven ability independently planning projects, formulate objectives and manage programs in line with ISO 13485
- Solid knowledge of CE certification process to support safe products to market.
- Excellent customer service and interpersonal skills, a clear communicator, fluent speaking English