Job Detail

Location Tipperary
Salary Negotiable
Posted
Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie

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/ talent@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ 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

JOB-11454

Senior Regulatory Affairs Supervisor

Marchon Monroe

Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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