About Us
Barrington James is recruiting for a Director of Quality Assurance and Regulatory Affairs (QARA) to lead regulatory strategy and ensure quality compliance for a fast-growing Medical Device company based in Galway, Ireland.
The company is a fast-growing start-up in the medical device industry, focused on bringing cutting-edge fitness and wellness technologies to market.
Key Responsibilities:
* Lead and manage all Quality Assurance and Regulatory Affairs activities, ensuring full compliance with FDA and other international medical device regulations.
* Develop and implement QA strategies to support R&D, production, and commercialization efforts.
* Oversee product certifications, regulatory submissions, and approvals, particularly in the U.S. (FDA) and Europe (CE marking).
* Provide strategic leadership and guidance to the team, ensuring high standards in quality management systems.
* Work closely with cross-functional teams to ensure the seamless integration of regulatory and commercial strategies.
* Foster a start-up mindset, promoting agility and adaptability in a rapidly evolving environment.
Qualifications & Experience:
* Proven experience in the medical device industry, specifically working with FDA regulations.
* Background in R&D within the medical devices space (preferred).
* Strong leadership skills with the ability to lead cross-functional teams.
* Commercially savvy, with a keen understanding of how regulatory frameworks impact business success.
* Based in Ireland, with flexibility for remote working.
* Ability to thrive in a dynamic, fast-paced start-up environment.
Requirements:
Minimum 500 words
Estimated Salary: €80,000 - €110,000 per annum
The company offers a competitive salary, along with an attractive benefits package.