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.
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