Regulatory Affairs Professional

Role Overview

• Leading development and execution of global regulatory strategy in collaboration with interdisciplinary product teams in compliance with international regulatory requirements and the Quality Management System.
• Preparing, submitting, and managing regulatory dossiers required for new product marketing and modified product applications in a global market.
• Preparing, submitting, and managing Technical Files in compliance with the requirements of the European Union (EU IVDR).
• Prepare, submit, and manage FDA marketing submissions including PMA (including Annual Reports and Supplements), 510(k) Pre-Market Notifications, and Pre-Submissions.
• Acting as a Regulatory Affairs subject matter expert on new product introduction and design control teams.
• Advising teams on regulatory requirements including labeling reviews, R&D and clinical study design, and design change regulatory impacts.
• Participating in internal and external quality system and design dossier audits

Requirements

• Bachelor’s degree in scientific discipline
• Advanced degree preferred
• Minimum of 5 years of experience in medical device industry
• Experience with medical device regulatory submissions is preferred
• Skilled in Outlook, SharePoint, Adobe Acrobat and Microsoft Office applications, including Excel
• Intercultural sensitivity
• Strong attention to detail and excellent organizational skills

Benefits

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time