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? Join us as Senior Manager Regulatory Affairs & Quality Assurance, overseeing the HeartSine AED product portfolio (Class III medical device).
Your key responsibilities
Leadership: Lead and inspire a team of regulatory and quality professionals, comprising 2 managers and 2-3 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.
What are we looking for?
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.
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.
We offer relocation support for candidates who may need to move for this position to Northern Ireland, including a full package that covers shipment, taxation support, housing, etc.
Thanks to our flexible working hours model, you will have the opportunity to work 1-2 days per week from the home office.
Please note that the internal job title may differ from the ad title.
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