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Senior Compliance/Audit Specialist

Job Title: Senior Compliance/Audit Specialist
Contract Type: Permanent
Location: Galway
Industry:
REF: 89243
Job Published: about 2 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

Senior Compliance/Audit Specialist
Our client, a medical device company in Galway are currently looking to recruit a Sr Compliance/Audit Specialist for their site.

Our Offer
  • You will contribute to the development of the annual internal audit schedule and related risk assessment.
  • You will be responsible for conducting frequent internal audits and compliance risk assessments.
  • You will provide compliance expertise and guidance in interpreting government regulations, agency guidelines, and internal policies.
  • You will be leading/supporting the implementation of compliance strategies supporting Medtronic CVG.
  • You will lead/support the investigation and resolution of compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
  • You will participate in the coordination and/or preparation for external agency audits and compliance reviews in accordance with regulatory standards (includes FDA, PMDA and BSI).
  • You will develop and maintain a working knowledge of current regulations and standards applicable to Medtronic's quality systems.
  • You will generate and monitor leading indicators of compliance to predict and resolve potential or real compliance gaps.
  • You will interpret and apply regulatory and other established requirements fairly and objectively.
  • You will support the development of a culture of self-assessment and constant audit readiness.
Qualifications
Your Profile
  • We are looking for a qualified person to Level 8 Degree in Quality, Engineering or Technical/Science related discipline and desirably with 5 years relevant experience. You are a dynamic team player and can work effectively and proactively on cross-functional teams. You are experienced with working in Medical Device industry in a Quality/Engineering/Compliance or equivalent role. Project and people leadership skills and experience are desirable. Green/black belt Lean and/or Six Sigma preferred. You are a good communicator and fluent in English, both in writing and speaking as well as demonstrating good organizational, presentation and project management skills. The ability to communicate effectively at all levels and functions in the organization.
  • Leadership Expectations provide the framework for what we expect from all employees at the company - outlining the actions and behaviors we must develop and demonstrate in pursuit of our Mission and global growth goals.
Shape
We are committed to being experts in what we do, with a clear vision of where we are going and the plan to get there.
  • Demonstrates Global Business Acumen
  • Thinks Critically and Makes Sound Decisions
  • Sets Strategic Direction
Engage
We partner with and involve others, knowing that diverse talent, skills, and perspectives lead to better outcomes.
  • Collaborates and Creates Alignment
  • Attracts, Deploys, and Develops Talent
  • Fosters Diversity and Inclusion
Innovate
We are bold thinkers who create new ideas and bring our best solutions forward to benefit our patients, partners, and customers.
  • Focuses on Patient and Customer
  • Generates Breakthrough Ideas
  • Initiates and Leads Change
Achieve
We do what we say we are going to do, delivering results with the highest standards.
  • Sets High Standards
  • Instils Operational Excellence
  • Drives Accountability
  • Models Ethical Behavior

For further information on this Sr Compliance/Audit Specialist role in Galway please contact Bimi Felix on 0868395533 / bimi@hero.ie
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