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Details

QA/RA Director -Start Up Medical Device


Reference:JCAO0406 Location: Galway
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs Director

Our client an early stage start up medical device company are currently seeking an experienced Manager/Director of QARA. The QA/RA Director/Manager will be a key early employee in a valuable leadership position, you will be joining a senior leadership group steering the company’s growth, value & culture. The Director of Quality Assurance & Regulatory Affairs will own & shape the Regulatory & Quality System functions. The appointee will be the main point of contact for regulatory authorities & notified bodies for the market introduction in 2024 of a Class II medical device, alongside a future pipeline of high-impact, patient-focused health products. This is a full time, permanent role based in Galway, Ireland with a hybrid work-from-home opportunity & flexible working hours. Limited travel will be required depending on the project phase. The Director of QARA will report directly to the CEO. A highly competitive remuneration package is available commensurate with experience & incorporating share options to enable the successful candidate to share in the company’s overall value as we grow.



Role/Responsibilities:

• Responsible for the development, implementation & maintenance of Quality Management System (QMS) to ISO 13485 for its medical devices & oversee employees & contractors/partners in using the QMS.

• Develop regulatory approval strategies for a Class II medical device in the US, Europe and ROW to ensure rapid translation of benchtop R&D to clinical implementation. Have hands-on ownership of regulatory submissions for clearance/approval.

• Set up & implement the day-to-day activities within the business’ Quality Management System.

• Ensure Quality System processes are lean, compliant, user-friendly & are well understood throughout the organisation.

• Enhance a compliance culture throughout the organisation. Carry out training & communication activities with employees and stakeholders on current & new regulatory requirements to ensure adequate understanding of Quality Systems, Regulatory requirements & product compliance.

• Lead the team in identifying key regulatory & quality risks, identifying mitigation strategies, & reporting on these regularly to the wider team. Develop a risk register for internal risk management & for submission to regulatory authorities.

• Draft & lead ethics & regulatory approval documents for clinical studies.

• Negotiate with regulatory authorities throughout the product lifecycle.

• Provide input into overall company strategy as a member of the senior leadership team.

• Manage external and internal audits.



Skills/Experience:

• Expert knowledge of ISO 13485, ISO 60601, ISO 14971, FDA Quality System Regulation, FDA 510k and De Novo Pathways, and EU MDR.

• Direct experience in leading the regulatory submission of medical device projects through FDA 510k clearance or De Novo approval. You have personally prepared and submitted materials to the FDA for clearance/approval of a medical device.

• Direct experience in interfacing with clinical teams in the regulatory approval of clinical studies. You have personally prepared and submitted materials for regulatory authority approval of inhuman clinical studies of a medical device.

• Direct experience of implementing a Quality Management System within a medical device development environment.

• Demonstrated people management skills, preferably within a Medtech environment. You are able to show examples of interfacing with R&D, Operations and Clinical teams to ensure regulatory and quality requirements are met.

For further information please contact James Cassidy [email protected] or call in confidence 0860204322