Principal Regulatory Affairs Specialist - Electrophysiology

Minimum of a Bachelor's Degree Minimum of 7 years of Regulatory Affairs experience in the medical device industry, or 5 years' experience with an advanced degree (Master's or PhD) Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs Strong technical, research and problem-solving skills Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat Bachelor's Degree in scientific, technical, or related discipline Experience working directly with FDA, notified bodies and/or international health authorities Prior experience with electrophysiology and/or medical electronic equipment products Able to work independently with minimal supervision Demonstrated leadership, strategic thinking, project planning, and project management skills Able to work well in fast-paced cross-functional team environments Ability to articulate complex ideas clearly both verbally and in writing Demonstrated ability to develop strong relationships with regulatory agency staff Demonstrated ability to effectively lead multiple regulatory projects and priorities Prior experience providing technical guidance, training, and/or mentoring to Regulatory Affairs and/or cross-functional peers