Head of Regulatory and Quality Affairs

Head of Regulatory and Quality Affairs

Full time

Ireland, Hybrid, or Remote ±2 hours GMT

Company Overview

Cergenx is an innovative medical device company based in Ireland, focused on developing cutting-edge neurotech devices for newborns. Our first device leverages EEG technology combined with AI to detect potential brain injuries at birth, using a simple, 15-minute test. 

Job Description

Cergenx is looking for a dynamic regulatory and quality leader who is adept at regulatory strategy, leading quality systems across cross-functional teams, and is effective across the full spectrum of startup regulatory and quality needs.  The Head of Regulatory and Quality Affairs will create and execute the company’s regulatory strategy and support the development and implementation of our quality system.  We are looking for a leader to partner with the CEO and leadership team to influence business strategy, drive quality across the organisation, and be the company’s external interface to regulatory agencies.  This critical and high-profile role will report to the CEO. 

The candidate will have hands-on experience and success in setting and executing regulatory strategies for novel technology products.  The ideal candidate will have experience in the regulation of medical devices (including software as a medical device) with experience in both the US and Europe.  Additionally, the candidate will have experience in building and implementing quality systems to meet market needs and over time, building high-functioning teams to support both the regulatory and quality functions.


  • Plan and lead regulatory affairs, including preparing submissions for FDA and Notified Body approvals

  • Serve as Management Representative for the company’s FDA QSR and ISO 13485-compliant quality system, responsible for procedures and policies that meet the requirements of our target markets

  • Liaise with government and regulatory officials in obtaining product approvals 

  • Provide leadership and training for the organisation to ensure that colleagues integrate quality system methods into product development

  • Collaborate with development teams to guarantee that development plans incorporate the necessary design controls to produce products meeting regulatory standards

  • Collaborate with the team and external clinical advisors to ensure test plans and studies provide the necessary clinical validation of company technologies 

  • Maintain an active effort to stay current with the changes taking place to applicable global standards and regulations 

  • Work very closely with company development teams to provide informed, creative and effective solutions to the many regulatory challenges the team faces in getting products through to commercial release 


  • Bachelor’s degree in a scientific discipline or technical field, or equivalent 

  • Minimum 8+ years of experience in medical device/software quality assurance and regulatory affairs

  • Experience managing successful FDA and CE approvals for medical technology devices including, including regulatory strategy planning, clinical study planning and regulatory body submissions

  • Experience implementing regulated medical technology products with significant software components

  • Deep and current understanding of quality system and regulatory requirements for medical technology and devices worldwide, including FDA CFR 21Part820, ISO 13485, Regulation (EU) 2017/745 (MDR), ISO 14971, IEC 62304, among others 

  • Experience mapping software development processes to meet FDA and IEC/ISO requirements while using agile methodologies highly desirable

  • Experience as Management Representative for FDA and Notified Body audits and experience conducting internal audits

  • Ability to work in a dynamic entrepreneurial environment where job descriptions are not narrow and all team members take an expansive view of their individual responsibilities

  • Ability to exercise independent judgement in devising regulatory plans and actions 

  • Excellent writing and communications skills with a highly analytical, meticulous approach to solving complex problems

  • Working knowledge of EEG and of machine learning or artificial intelligence is a plus, but not required

  • Experience with Regulation and on data security and privacy including ISO27001, and General Data Protection Regulations. Experience as Management Representative for FDA and Notified Body audits and experience conducting internal audits