- Reference: GJ456456
- Job Type: Permanent
- Location: Clare, Galway, Galway City
- Category: Medical Devices
Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let’s work together to address the universal healthcare needs and improve patients’ lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.
At our Regulatory Affairs department, we focus on harnessing our collective strength to deliver best-in-class solutions that benefit patients and our cross functional partners. Senior Regulatory Affairs Specialists are directly involved in regulatory activities supporting the global commercialization and sustaining of products on the market in compliance with all regulatory requirements.
You will contribute to the activities of our Regulatory Affairs group and demonstrate flexibility as priorities change. You will be responsible for supporting department goals. You will be responsible for the review and approval of Change Requests and taking action on International Requests. You will lead the planning and execution of Global Product Registrations/Submissions. You will participate as part of a project team to obtain information in support of these registrations and communicate with multiple contacts in international regions. You will communicate with external regulatory agencies (FDA, notified bodies etc.) during the registration process. You will support new product development as an extended RA core team member. You may be required to interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements. You will identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS).
Leadership Expectations provide the framework for what we expect from all employees at Medtronic – outlining the actions and behaviors we must develop and demonstrate in pursuit of our Mission and global growth goals.
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
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
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
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.