Quality and Regulatory Affairs Consultant

The Quality and Regulatory Affairs Consultant will work within Emergo’s regulatory affairs team and support Emergo’s global consulting services, providing assistance with regulatory and compliance issues. May also be called upon to liaise with local consulting partners and regulatory authorities in smaller markets where needed.

• Bachelors' degree, preferably in a Medical, Engineering or Science field.
• Advanced, professional-level written and verbal English and excellent communication skills.
• Generally, 2-5 years of Quality Assurance and/or Regulatory Affairs experience working in the medical device field, in a regulatory, submissions or quality support role.
• Consulting experience a plus.
• Excellent attention to detail, research or device registrations experience a plus..
• Proficiency with Microsoft Office software.
• Strong multitasking, organization and prioritization skills.

What you’ll experience working for ULS 

UL Solutions has been pioneering change since 1894 and we’re still leading the way. From day one, we’ve blazed a trail protecting the planet and everyone on it. Our teams have influenced billions of products, plus services, software offerings and more. We break things, burn things and blow things up. All in the name of safety science. 

That’s where you come in — because none of it could happen without you. It takes passion to protect people, problem-solving to safeguard personal data and conviction to make the world a more sustainable place. It takes bold ideas and brilliant minds to build a better world for future generations across the globe.  

This is more than a job. It’s a calling. A passion to use our expertise and play our part in creating a more secure, sustainable world today — and tomorrow. As a member of our safety science community, you’ll use your ideas, your energy and your ambition to innovate, challenge and ultimately, help create a safer world. 

Everyone here is unique. But we’re also a global community, working together to help create a safer world. Join UL Solutions and you can connect with the brightest minds in the business, all bringing their distinct perspectives and diverse backgrounds together to deliver real change. 

Empowering our customers to keep the world safe means thinking ahead. It means investing in training and empowering our people to learn and innovate. At UL Solutions, we help build a better future — one where everyone benefits. 

Join UL Solutions to be at the center of safety. To learn more about us and the work we do, visit UL.com

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• Assist consulting team and clients with the preparation and submission of medical device registration/licensing applications to a single or specific number of regulatory markets.
• Prepare renewals or amendments to the above, and act as support to a project team lead (project manager or consultant); this may include direct client interaction which should be well documented.
• Develop and leverage knowledge of requirements and expectations for medical device submissions, understand the registration process, including whether tasks should be completed in parallel or sequentially and clearly delineate each process/phase to clients.
• Assist with client documentation review, gap analysis, provide input regarding the acceptability of existing data, and explain how to satisfy the submission requirements.
• Assist with or redirect internal or external inquiries related to quoting project hours and scope, including potential grouping or classification as applicable.
• Escalate complex regulatory issues identified by team or clients to senior experts as appropriate and follow through to resolution.
• Prepare regulatory reports.
• Perform activities such as: - Research on regulatory issues, involving web searches, review of internal library and other means - Summarizing technical and regulatory information in a written form - Serve as Lead Consultant on multi-market research projects as needed - Handle client inquiries and provide consultation regarding medical device quality assurance and regulatory compliance issues, such as: - Drafting / reviewing mandatory or operating procedures needed for quality assurance or regulatory compliance - Reviewing product labeling - Responses to issues arising from registrar or regulatory inspections / audits.
• Act as regulatory support on larger consulting project teams comprised of multiple stakeholders, including senior consultants, business development and project management.
• Where appropriate, act as initial liaison with local regulatory authorities on behalf of clients.
• Support Consulting team with RA and QA priorities as needed. Read and follow the Underwriters Laboratories Code of Conduct and follow all physical and digital security practices.