Lead Quality & Regulatory Affairs Consultant

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.

Quality Assurance:

• Perform Quality Management (QMS) assessments and audits for compliance with the FDA QSR, ISO 13485, MDSAP, EU MDR, IVDD/IVDR and other country-specific regulations for medical device manufacturers worldwide.
• Develop and deliver standard or customized training modules to clients on quality and regulatory-related topics
• Provide additional Quality Consulting services such as:
  • Preparing & assisting manufacturers with external audits (e.g., ISO registrar, FDA, Notified Body); attending audits to act as subject matter expert, where called upon.
  • Conducting internal / supplier audits (as a lead auditor)
  • Gap analysis and remediation of QMS for a diverse number of manufacturers with a wide array of medical products
  • Supporting with maintenance and/or updating client compliance to additional requirements (e.g., MDSAP, EU MDR/IVDR)
  • Review and assess compliance during acquisition due diligence activities; perform due diligence audits as requested
  • Strategic, Training and Support
  • Customize consulting solutions to clients’ specific needs, both on-site and off-site
• Perform Lead Consultant role in multi-faceted projects; provide guidance and feedback to other team members during the project.
• Perform peer reviews of colleagues’ work output to ensure high-quality, consistent deliverables
• Join and support Sales in client calls to demonstrate Emergo’s expertise
• Provide Emergo management and colleagues with updates regarding changes to global regulations and policies as well as feedback from clients / regulatory authorities
• Effectively manage workflow to meet business goals and objectives. Provide regular reports to management regarding individual capacity, forecasting and other business metrics
• Coordinate with other UL offices on global service requests. Collaborate in scoping out work and developing proposals and statements of work to meet customer needs.
• Participate in developing and maintaining internal Emergo procedures and QMS
• Respond to internal requests for advice and guide others as an SME
• Review and advise on labeling and marketing content
• Develop and present trainings to colleagues regarding regulations and procedures to ensure a continued state-of-the-art knowledge base.
• Read and follow the Underwriters Laboratories Code of Conduct, and follow all physical and digital security practices

• Bachelor’s degree or equivalent in a scientific discipline, particularly biomedical engineering, quality engineering, microbiology or chemistry
• • 8 years of Global Quality Assurance and Regulatory Affairs Medical Device industry experience, ideally at a Team Leader/Managerial / Director level
• A demonstrated knowledge and understanding of global medical device regulations, especially MDSAP countries and the EU / UK
• A demonstrated knowledge and understanding of the Australia TGA medical device regulations and a min. of 1 year of experience in delivering Australia Sponsor services.
• RAC, CQE, CQA or other quality certification preferred
• Auditing experience to medical device standards (QSR, ISO 13485, MDSAP), a Lead Auditor Certification is an advantage
• Experience with writing and compiling technical documentation
• Client-facing experience and strong interpersonal skills with the ability to work with C level executives of a client’s organization
• Fluency in English.

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.