Belfast, GBR
23 hours ago
Senior Manager RAQA - Medical Devices
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific. 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 withClass 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. \#IJ Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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