Regulatory Affairs Supervisor

About the opportunity:

My client is a Munster based medical device multinational with a new requirement for a Regulatory Affairs Supervisor on a permanent basis. This role is commutable form Tipperary, Cork, Waterford and Kilkenny. As the RA Supervisor you will establish and maintain effective quality system structures to ensure consistent implementation of quality systems. You and your department create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance and standards.

Job Responsibilities:

• Will act as an expert resource in external regulations and standards requirement knowledge for cross functional teams.
• To be 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 the company’s global 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
• Participate cross functionally and across business units to standardize the 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.
• Assure that appropriate resources are maintained in order to assure Quality System compliance and adherence.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Essential Qualifications:

• Degree qualified (Level 8) in Regulatory Affairs/Quality or other related discipline
• 6+ years relevant Regulatory Affairs experience. Minimum of 2 years in an RA Lead/Manager capacity.
• Medical Device Experience with the EU,UK or US is essential.

For further information on this role, please contact Marchon Monroe on 0860449473 / talent@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Marchon Monroe

JOB-11352