Regulatory Affairs Manager

2 days ago

Galway, Ireland Perfuze Full time

About PerfuzePerfuze is a growth stage medical device company, based in Galway, dedicated to improving the quality of life for stroke patients.Perfuze is developing innovative catheter-based technology to remove clots from the brain following Acute Ischemic Stroke.At Perfuze, our mission is to halve the number of patients who suffer disability post stroke treatment.We want to accelerate and advance our ability to create significant innovations, but we will only succeed with the right people on our team.Perfuze is based in Dangan on the west side of Galway City.Our Cultureo An inclusive work environment, where all the employees are valued, supported, and encouraged.o All employees have a seat at the table and have influence.o A collaborative teamwork environment where learning is constant, and performance is rewarded.o The opportunity to be at the forefront of a technology that can positively impact the treatment of one of the world's most devastating diseases.Regulatory Affairs ManagerThe Regulatory Affairs Manager is responsible for regulatory compliance activities at Perfuze.The position requires a high level of innovative thought, problem-solving skills and structured time and task management.Responsibilities o Define regulatory strategy for new products and oversee all regulatory activities required for sustaining existing product approvals/clearances.o Oversee all regulatory filings, including 510(k) and CE mark submissions, associated regulatory interactions, and product registrations.o Develop and maintain relationships with regulatory agencies, including FDA and our Notified Body.o Monitor changes to applicable regulations and incorporate these into the regulatory strategy for Perfuze products that is consistent with company goals.o Work with Quality Assurance to ensure all post-market surveillance and vigilance activities are performed according to applicable European and US regulations.o Oversee regulatory review process for advertising and promotional material.o Identify and manage resources required for effective functioning of regulatory process.o Provide strategic guidance to Perfuze team on regulatory issues.Requirementso Degree in Engineering, Science or health-related discipline.o 10+ years' experience in the medical device industry, preferably 3 of which were in a management role.o Deep understanding of US and EU regulatory requirements for medical devices.o Strong self-management and organisational skills, ability to manage workload, ability to set and adjust priorities to align with company goals.o Proven ability to manage and coach others effectively.o Good interpersonal & communication skills essential.o Excellent communication and comprehension skills.o Experience working in an SME environment, preferably in a medtech start-up.o A hands-on mindset.If interested, please submit your CV and a letter outlining why you are the right person for the role

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