Lead Quality

**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:

- 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