Senior Regulatory Affairs Specialist | Collins McNicholas

Senior Regulatory Affairs Specialist

  • Reference: GJ456456
  • Job Type: Permanent
  • Location: Clare, Galway, Galway City
  • Category: Medical Devices
FURTHER, TOGETHER
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.

OUR PURPOSE 
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.

OUR OFFER
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). 

Qualifications
YOUR PROFILE
We are looking for a qualified person to Level 8 Bachelor’s Degree/Masters or equivalent in Science or a relevant discipline. Regulatory experience is preferred, however, candidates with a minimum of 5 years relevant medical device industry experience will also be considered. You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams. You are experienced with Microsoft Word, Excel and Powerpoint, and knowledge of Adobe Acrobat and Data Management Systems are preferred. You set high standards and drive accountability in the execution of your responsibilities to deliver consistent decisions, actions, and results. You have strong technical knowledge. You are skilled in thinking critically and demonstrate good judgment. You collaborate with others, seeking different perspectives and ideas to foster an inclusive work environment. You promote and practice a culture of integrity, ethics and compliance with laws and policies. You are a good communicator and fluent in English, both in writing and speaking with strong organizational and time management skills.

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. 

SHAPE
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

ENGAGE
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

INNOVATE
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

ACHIEVE
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.


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Christopher O'Toole

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  • Senior Recruitment Consultant
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