Published Description:
Job Title: Regulatory Compliance Specialist
Location: Kelso, Scottish Borders, Scotland
Purpose Statement: The Regulatory Compliance Specialist supports the site by providing guidance in quality management for the respective regulatory (Medical, Aerospace/Military/Defence, Industrial, etc.) requirements for end-to-end manufacturing, repair processes, operations, defect prevention system establishment and maintenance.
Key Job Accountabilities:
Understand and maintain knowledge of all applicable industry compliance regulations and standards required, including but not limited to ISO 9001, ISO 13485, ISO 14971, QSR, ITAR, AS9100, NADCAP, etc. quality and risk management systems. Support customers by providing relevant documentation for regulatory submissions
Lead the site in ongoing audit and inspection readiness activities, preparing for and participating in/host site quality and product audits by internal audit staff, customer, or regulatory resources (including UL, CSA, TUV, etc.)
Perform assigned site and regional internal audits, supporting the development and execution of the internal audit program
Aid Site with root-cause analysis, corrective/preventive actions and continuous improvement across common quality issues (for CAPA/CCM/NC/SCAR as required) Perform compliance CAPA approvals where required
Support the processes for change requests, validation documentation and risk management documentation
Perform regular reviews of the operational areas to ensure Good Manufacturing Practices are consistently and appropriately utilised
Additional Accountabilities:
Escalate issues and roadblocks that are preventing progress and success
Drive continuous program/process improvements using statistical/analytical improvement tools such as Six Sigma and lean methodologies.
Participate in corporate projects.
Occasional travel may be required to meet the needs of the business (estimated 10% to 20%).
Additional duties as assigned.
Education/Experience Qualifications:
A minimum of a Bachelor’s degree is required
Experience of using Quality Systems Tools is required
Strong working knowledge of Regulatory and Standard requirements for CAPA is required
Experience with Problem solving methodologies is required; Lean six sigma certification is preferred
Experience in pFMEA and Control Plan development is preferred
Internal Audit experience is required; internal audit certification is preferred
Experience in an Aerospace/Military/Defence product environment preferred though experience in a medical device product environment would be considered.
An equivalent combination of education and experience sufficient to successfully perform the key job accountabilities may be considered.
Other Qualifications:
Intermediate Computer Skills
Advanced Decision Making, Problem Solving Skills
Advanced Verbal and Written Communication Skills
Project Management Skills
General office equipment and materials