Based in Dublin, our client is a start-up medical device company developing a novel cardiac product to address unmet patient needs which significantly impacts on the patient’s quality of life.  Following a very successful funding round, they are now adding to their management team with the appointment of a Quality Assurance and Regulatory Affairs Manager.  This is a key appointment for the company and an excellent opportunity for a motiovated individual seeking a challenge and the opportunity to bring a breakthrough product to full approval and commercial scale.

Key responsibilities will include: 

• Take ownership of the QA agenda encompassing Quality, Regulatory and Clinical management to obtain full approval for the product, leading to commercial approval.

• Integrate the medical, scientific, business and governmental-regulatory elements of the Company to create an ethical and vigorous synthesis.

• Develop and implement goal-directed efforts across the business and departmental resources.

• Monitor actions of global regulatory agencies and participate actively in policy discussions with industry and agencies when applicable/appropriate.

• Develop, monitor and control a budget in conjunction with the CEO.

The ideal candidate will be qualified with a Degree in related scientific fields or equivalent.  Strong people management and relationship skills with a demonstrated ability to educate, guide and influence across the business, as well as outside agency personnel is essential.

The position requires extensive technical and regulatory knowledge related to medical devices in general and cardiac devices.