Senior Quality

Provide Quality and/or Regulatory consulting services, independently or with oversight by a Lead QA/RA Consultant or Consultant Manager, which may include but are not limited to:
- Leverage regulatory affairs experience gained in the medical device industry/medical device consulting to provide client support with Quality Assurance and Regulatory compliance requests, help resolve client issues, and respond to market-specific inquiries
- Prepare/review local or international regulatory submissions e.g., Brazil registrations for or on behalf of manufacturers, demonstrate and share knowledge of requirements by market and compile/review technical documentation files for compliance to applicable regulations; raise concerns where any are identified, provide guidance for resolution
- Perform research on regulatory affairs requested for standard or nuanced market environments and generate peer reviewed reports
Provide Regulatory consulting services, such as:
- Research and prepare regulatory classification and strategy / pathway reports
- Review and identify gaps in technical / regulatory documentation
- Prepare premarket submissions to regulatory authorities
- Perform literature searches and prepare Clinical Evaluation Reports
- Assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities
- Guidance on testing requirements to support marketing submissions
Provide Quality Assurance consulting services, such as:
- Implementation of Quality Management System (QMS)
- Draw from medical device industry experience for analysis of existing client QMS against requirements and gap closure and remediation as needed
- Conduct Internal audits / Supplier audits for manufacturers, distributors and vendors
- Maintenance and/or updating of QMS with additional requirements
- Review and advise on labeling and marketing materials, including written documents and website
- Read and follow the Underwriters Laboratories Code of Conduct, and follow all physical and digital security practices
- **Mission**: For UL, corporate and social responsibility isn't new. Making the world a safer, more secure, and sustainable place has been our business model for over 125 years and is deeply ingrained in everything we do.
- **People**:Ask any UL employee what they love most about working here, and you'll almost always hear, "the people." Going beyond what is possible is the standard at UL. We're able to deliver the best because we employ the best.
- **Interesting work**:Every day is different for us here as we eagerly anticipate the next innovation that our customers create. We're inspired to take on the challenge that will transform how people live, work, and play. And as a global company, in many roles, you will get international experience working with colleagues around the world.
- **Grow & achieve**:We learn, work, and grow together with targeted development, reward, and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles.
- 5+ years **IVD **regulatory affairs experience
- Knowledge of IVD regulatory requirements for the Brazil Market (Brazil RDCs)
- Experience with international medical device and IVD regulations is considered an advantage
- Strong interpersonal skills and ability to work with all levels of a client's organization
- Commitment to excellence in deliverables and customer service
- Effective technical writing skills
- Ability to identify, understand and resolve issues
- Professional, but friendly demeanor; diplomatic but assertive
- Effectively manages one's time to ensure that work is completed efficiently and within the budgeted time, and is capable of successfully working on multiple projects
- Remain up to date with new policies, guidance, standards and regulations
- Ability to understand the big picture and at the same time is detailed-oriented
- RAC, CQE, CQA or other similar equivalent certifications preferred
- This role requires an Advanced level of business and technical English (oral and written)
LI-BD1
Remote

---