Our client, a biotech pioneer in organ transplant technologies and therapies, is in immediate need of an experienced Regulatory Affairs Specialist.
Help make a difference in the lives of many.
Job Duties and Responsibilities:
• Prepare and maintain regulatory submissions and registration of complex Class III devices in the US and in international markets.
• Maintain documentation and perform project management tasks, including record keeping and tracking due dates for FDA and international regulatory submissions.
• Assist with the preparation of FDA applications and other international regulatory documents, including EU Technical Files and documentation related to EU MDR certification.
• Assist with vigilance reporting in the US and around the world.
• Serve as liaison with Quality and Engineering team members and provide support with FDA and EU regulations; participation in FDA and notified body audits as required.