Vice President, Category Quality & Regulatory Affairs - Remote

Posted 05 January 2024
Job type Permanent
DisciplineLife Sciences & Engineering Technologies, Science Leaders & Specialists
ContactShane Browne

Job description

This innovator is one of the world's largest medical devices organisations globally, with operations across the Americas, Europe and Aisa Pacific, serving patients in fields such as Vascular, Cardiac and Neuromodulation, to name but a few. With an extensive portfolio of over 40 commercialised products, this company provides innovative, high-quality technologies and manufacturing services to enhance the lives of patients worldwide. With over 80 years of industry changing innovations, this business has grown extensively through pipeline development and an agressive acquisition strategy. It's legacy provides it's customers with unparralleled expertise and innovation, and is guided by it's values, which are centric to this organisation's success. This is a truly exciting time to join this growing organisation as a Vice President of Category Quality & Regulatory Affairs (C&V).

The Position

  • Adheres to and role models organisational Core Beliefs and Guiding Principles and all safety and quality requirements; holds direct reports and team accountable to similar behaviors.
  • Manage all aspects of the quality and regulatory system across the applicable sites, driving to a standardised system based on best practices.
  • Is the principal Quality escalation contact and advocate to customers in assigned Product Category and represents Quality in Product Category customer business reviews, executive partnership meetings and customer escalation events, establishing and maintaining customer communications and credibility as the organisational champion.
  • Interfaces directly and regularly with internal and external customers. Responsible for projects that are of the highest priority with high visibility by customers. Proactively manages the risk associated with Quality concerns, including but not limited to design assurance elements of test method validations, sample size selection etc.
  • Communicates regularly with executive management and administration regarding the management of current projects; obtains executive management guidance and approval as required.
  • Responsible for success of activities to streamline Quality processes to ensure consistency with the Businesses Systems within the Product Category and alignment with global owners of such Quality System processes.
  • Drives consistent use of QA/RA KPIs across responsible plants to ensure measured performance improvements based on root cause analysis and defining/deploying appropriate preventive and corrective actions.
  • Reviews Quality Agreements for site related agreements in alignment with Global QS and legal review.
  • Adheres to the standardised enterprise procedures and controls related to environmental monitoring, sterilisation and biocompatibility in accordance with industry, customer and organisational requirements.
  • Responsible for analysing site assessment and audit trends to develop best practice processes.
  • Interviews, hires, and establishes training plans for direct reports. Provides leadership to the supervisory staff regarding development of individuals' goals and mentoring of the group.
  • Able to systematically identify and resolve complex problems with an analytical data driven approach and creative thinking.
  • Performs other duties as required.

The Person

  • Bachelor's in Science, Engineering or a technical discipline. Master's degree preferred.
  • Minimum 12+ years of experience in Quality Assurance/ Regulatory in a medical device development and manufacturing environment.
  • 10 years of management experience in a medical device development and manufacturing environment with multi-site responsibility.
  • Establish and maintain networks, influence in a matrixed organisation, and communicate in a clear and highly professional manner.
  • Demonstrated ability to establish, communicate, and implement long-term strategic and operational goals.
  • Effectively manage a large workflow and multiple projects at one time.
  • In-depth Medical Device Quality Management System knowledge and experience.
  • Organised and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm.
  • Experience and expertise applying change management principles and practices to drive successful enterprise transformation.
  • Demonstrated influencing skills with all levels of key stakeholders during times of transformation and other situations.
  • Project management, team development, and management skills.
  • Knowledge of applicable laws which regulate medical device manufacturers.
  • Strong leadership skills with demonstrated ability to drive positive results.
  • Ability to work through difficult issues with suppliers, customers and regulatory bodies.

To discover more about this opportunity, apply now or contact Shane Browne at HRM Search Partners on +353 1 6321865 for a confidential discussion.