REGULATORY AFFAIRS:

• Leverage extensive medical device industry/consulting experience to provide expert level regulatory consulting services.
• Develop effective product registration strategies for customers (product classification and solutions for bringing product to the market)
• Use medical device background knowledge to perform critical review and gap analysis of product documentation and regulatory submissions
• Prepare high-quality premarket submissions, e.g., FDA 510(k) / de novo, Canadian MDL, EU, Australia TGA, Technical Documentation Files, and other global registrations
• Request and support Pre-Submission meetings and liaise with government authorities on behalf of client.
• Assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities
• Provide SME guidance in all aspects of global Medical Device and In Vitro Diagnostic (IVD) regulations
• Develop Clinical Evaluation / Performance Evaluation Plans & Reports
• Support with strategy and submissions for novel devices/technology: FDA Breakthrough Device Designation / de novo submissions; Health Canada guidance communications; other international markets as needed.
• Specialized support in areas such as SaMD, cybersecurity, risk management, sterilization, etc.
• Use industry experience to guide and assist manufacturers with meeting Post-Market requirements, e.g., change management and promotional compliance.

OTHER DESIRED COMPETENCY AND QUALIFICATIONS:

• Post-graduate degree
• Lead / external (e.g., supplier) auditing experience
• Clinical Evaluation report preparation
• Experience with IVDs and/or device software / SaMD
• Experience with presenting training to large groups, trade shows, industry events
• Fluency in additional languages.
  A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers’ product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers’ products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage

Please refer the Job description for details