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Responsibilities:

• Participate in product development/line extension teams as the need arises to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document and implement regulatory submission plans around product development/line extension goals.
• Drive Labelling and Copy review for products for domestic and International markets.
• Prepares and updates European and International technical files/dossiers/registrations as required and per applicable SOPs.
• Prepares U.S. FDA submissions (e.g., IDE, PMA, annual reports) as required and per applicable SOPs.
• Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and International regulations and standards.
• Ensure adequate documentation of compliance to FDA, European and International regulations and standards. Ensure Regulatory Affairs files are updated and maintained as required.
• Develop working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and BDPI Notified Body.

Requirements:

• Bachelor of Science or technical degree or equivalent experience
• Regulatory Affairs medical industry or related proven industry experience (medical device, pharmaceutical and/or healthcare), 0-3 years.
• Excellent written and verbal communication and technical writing skills
• Strong organizational and interpersonal skills
• Ability to optimally manage multiple projects with shifting priorities
• General knowledge of FDA and European medical device regulations, including IDE, PMA, MDD & MDR beneficial
• Able to apply independent decision making and analytical thinking skills
• Proficiency with PC computer and Microsoft Office software
• Technical knowledge of interventional vascular devices, related medical procedures and associated medical terminology preferred
• Ability to work independently with minimal direction