Our client, a global Medical Devices leader, are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. They are seeking an experienced Regulatory Team Lead to join a high-performing and established Regulatory team at their state-of-the-art manufacturing campus in Tipperary.
Duties and responsibilities of the Regulatory Team Lead will include but are not limited to:
- Will act as an expert resource in external regulations and standards requirement knowledge for cross functional teams. Is viewed as a leader in the areas of quality systems and ISO/MDD standards within one's own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis.
- Implementation of internal requirements and external laws, regulations, guidance's and standards as applicable to quality systems.
- Champions continuous improvement and innovation from a quality system perspective.
- Lead and support site External Inspections.
- Identify areas of potential noncompliance or improvements by managing and conducting internal audits to schedule
- Educate functional areas on quality system requirements.
- Participate cross functionally and across business units to standardize Quality System policies and procedures.
- Collect and analyze business/quality system process data from different parts of the company.
- Support the site corrective and preventive actions process.
- May on occasion be required to travel in order provide support the business or other sites in this area of responsibility.
- Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives.
You will have skills and experience in the following:
- BSc and 3+ years relevant industry experience, medical devices preferred
- Supervisory / leadership experience
- Experience working with Class III devices would be an advantage
- Strong communicator and ability to work cross-functionally
- Experience working with global teams would be beneficial
- Excellent collaboration skills to optimise the relationship with internal and external partners.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.