Overview

Drive regulatory excellence at our Healthcare Optics Research Laboratory for our biomedical devices in collaboration with world-leading medical institutions. We are seeking an experienced Medical Device Principal Regulatory Affairs Specialist (Advisor, Regulatory Affairs) professional who will define and execute the regulatory plans to obtain and maintain regulatory approvals within the US and international markets.

Responsibilities

• Participate on product development Core Teams assisting with regulatory assessments and planning; reviewing product development and clinical protocols and reports to ensure collection of appropriate data for regulatory submissions; and participating in risk assessments and design reviews
• Prepare regulatory assessments and plans for new products and design changes
• Preparation of regulatory submissions for product approval/clearance, including 510(k) premarket notifications
• Lead interactions with regulatory agencies needed to obtain product approval/clearance
• Review labeling, training, and promotional materials for compliance with claims and applicable regulations
• Assess product and manufacturing changes to determine regulatory impact
• Provide ongoing surveillance and analysis of FDA and international medical device regulations for impact on the company's products and regulatory procedures
• Communicate regulatory requirements to management, Core Teams and others; particularly new and revised regulatory requirements
• Develop and maintain regulatory procedures and policies to ensure compliance to applicable regulations
• Support US and international product registrations
• Support Investigational Device Exemption submissions
• Support post-market regulatory compliance activities for US and international products

Qualifications

• BS or higher degree in engineering, science, health care or similar
• 10 years medical device experience, including demonstrated experience in preparing successful domestic and international submissions
• Experience in acting as a liaison to and communicating with regulatory agencies
• Strong working knowledge of FDA and EU MDR (European Medical Device Regulation) medical device regulatory requirements
• Knowledge of Japanese and other international regulations is a plus
• MDSAP (European Medical Device Regulation) experience is a plus
• RAC (Regulatory AffairsCertification) certification is a plus
• Proficient in Microsoft Office
• Must possess strong oral and written communication skills

The company will not pursue or support visa sponsorship for this position.