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.
- 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.
- Degree qualified (Level 8) in Quality qualification
- +4 years of experience in Regulatory Affairs in the Medical Device industry.
For further information on this role please contact Marchon Monroe on 086 044 9473/ email@example.com 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.
Job ID: JOB-11533 Senior Control Systems Engineer Our client, a leading pharmaceutical company are currently sourcing a Senior Control Systems…
Job ID: JOB-11520 Packaging Engineer My world leading medical technology client are recruiting for a Packaging Design Engineer for a…
Job ID: JOB-11519 My client a leading pharmaceutical manufacturer of both medical and pharma products is recruiting for a QP…