Job Detail

Location Tipperary
Salary Negotiable
Role Type Permanent
Contact Marchon Monroe

Senior Regulatory Affairs Supervisor

Job ID: JOB-11454
Senior Regulatory Affairs Supervisor

My client in a Munster based Medical Device company with sites around the world! There is a new position available for a Senior Regulatory Affairs Supervisor who will join a well-established team and lead the further growth and development of the department. The key focus of your role as the RA Supervisor is to demonstrate a primary commitment to patient safety and product quality throughout your group.

Job Duties:

  • Establish and maintain effective quality system structures to ensure consistent implementation of quality systems.
  • Act as an expert resource in external regulations and standards requirement knowledge for cross functional teams.
  • Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance and standards.
  • Provide support to customer as required helping to ensure delivery of highest quality product.
  • Viewed as a leader in the areas of quality systems and ISO/MDD standards within your 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 site 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 company Quality System policies and procedures.
  • Collect and analyse business/quality system process data from different parts of the company.
  • Support the site corrective and preventive actions process.
  • Occasional travel may be required in order provide support the business or other site.
  • Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives.
  • Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Assures that appropriate resources are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.
  • Plans and organizes project assignments and maintains project schedules.
  • Independently determines and develops approach to solutions and assists in establishing departmental policies and procedures.
  • Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations.

Required Qualifications:

  • Degree qualified (Level 8) in Quality qualification
  • +4 years of experience in Regulatory Affairs in the Medical Device industry.

REF# 11454

For further information on this role please contact Marchon Monroe on 086 044 9473/ Check out all our open jobs on our HERO Recruitment website – Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Marchon Monroe


Senior Regulatory Affairs Supervisor

Marchon Monroe

Role Type Permanent
Contact Marchon Monroe
mobile +353 86 044 94 73
linkedIn profile click here

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