Senior Regulatory Specialist with at least 7 years’ experience in Quality Assurance or Regulatory Affairs with a track record of success with IDE, FDA 510(k) and PMA submissions required by innovative MedTech company in Galway

REQUIREMENTS:

• Bachelor’s or Master’s degree in a scientific or engineering discipline.
• 7+ years of experience in Quality Assurance or Regulatory Affairs within medical device companies, with a proven track record of success in IDE, FDA 510(k) and PMA submissions.
• Extensive experience in preparing and reviewing regulatory submissions to ensure timely approvals.
• A collaborative team player with strong knowledge of the medical device design and development process.
• Excellent written, interpersonal communication and presentation skills.
• Highly organized, with the ability to manage multiple projects effectively.
• Proficient in analytical and computer skills, with the ability to conduct research, analyze data and write technical documents.

RESPONSIBILITIES:

• Support and advise the VP of Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies that align with the business needs.
• Develop regulatory submissions to ensure timely product clearance or approval, leading the preparation, review and submission of high-quality responses to regulatory agency inquiries.
• Collaborate with the development team to ensure data generation follows best scientific principles, meeting submission goals and regulatory requirements.
• Develop and manage product design and technical documentation in compliance with relevant regulations and standards, ensuring data integrity and protection against corruption, misuse, or damage.
• Ensure compliance with applicable laws and regulations of relevant Health Authorities, maintaining product marketing rights and approval.
• Monitor emerging legislation and regulatory guidance across jurisdictions, contributing to company-wide awareness and ensuring compliance where necessary.