Senior Manager QA / Ra

Description:

A Senior Manager, QA / RA is required on a PERMANENET basis by CareerWise Recruitment for our Belfast-based multinational Medical Device Company.

Are you ready to lead a dynamic team of regulatory and quality professionals towards excellence in ensuring market access, product quality and compliance for life-saving medical devices? In this exciting role, the Senior Manager Regulatory Affairs and Quality Assurance will oversee the HeartSine AED product portfolio (Class III medical device).

THE ROLE:

• Leadership: Lead and inspire a team of regulatory and quality professionals, comprising 2 managers and 3 individual contributors, towards the achievement of business strategies for the HeartSine AED product portfolio.
• Regulatory Compliance: Monitor evolving regulations, ensuring adherence to governmental and internal standards while driving implementation strategies.
• Strategic Planning: Develop organizational strategies and metrics to enhance regulatory and quality processes, ensuring device conformity and post-market obligations.
• Cross-Functional Collaboration: Collaborate with various departments to align corporate goals and strategies, ensuring regulatory and quality objectives are met.
• Budget Management: Establish and manage budgets to optimize resource allocation and support effective operations.
• Talent Development: Recruit, onboard, and engage top talent, fostering a culture of continuous improvement and professional development.
• Representation and Advocacy: Represent regulatory and quality processes during audits and participate in advanced advocacy activities.

REQUIREMENTS:

You have successfully completed a Bachelor or Master of Science, Engineering or any related discipline.

You have 8+ years of relevant professional experience in RAQA within medical device industry, ideally with Class III products.

Furthermore, you have experience in managing a team of direct reports including people development.

You are ideally RAC certified (or equivalent).

You are characterized by a high level of communication skills, strategic thinking, analytical and negotiation skills as well as extensive interface competencies.

You enjoy working in an international and complex matrix-organization.

Your excellent English language skills enable you to collaborate with stakeholders on a global basis.