Quality & Regulatory Affairs Consultant

UL Solutions; Mexico; On-site; MXN 350,000 - 700,000; Full time

Job summary

UL Solutions in Mexico seeks a Regulatory and Quality Affairs Consultant to support global medical device registrations, liaise with authorities, and guide clients through regulatory pathways.

You will prepare submissions, analyze requirements, brief teams, and help ensure compliance across markets, using strong English communication and MS Office skills. Collaboration with local partners and senior consultants is common.

Qualifications

• Bachelor's degree in Medical, Engineering or Science field preferred.
• Strong written and verbal English communication skills.
• 2–5 years of Quality Assurance and/or Regulatory Affairs experience in medical devices (regulatory, submissions or quality support).
• Consulting experience a plus.
• Excellent attention to detail and ability to perform regulatory research.

Responsibilities

• Assist with preparation and submission of medical device registrations to regulatory markets.
• Prepare renewals or amendments and support project teams.
• Develop knowledge of submission requirements and communicate processes clearly to clients.
• Assist with client documentation review and gap analysis; advise on data acceptability.
• Escalate complex issues to senior experts and support resolution.
• Prepare regulatory reports and lead multi-market research projects as needed.
• Interact with local regulatory authorities on behalf of clients where appropriate.

Skills

English proficiency

Regulatory affairs

Medical device knowledge

Consulting experience

Attention to detail

Education

Bachelor's degree in Medical, Engineering or Science

Tools

Microsoft Office

Job description

Job Description

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.

Responsibilities

• 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.

Qualifications

• 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.

About Us

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.

About The Team

When you combine the gravitas of a 130-year-old safety science leader with a culture of innovation that pushes the boundaries in new services and technology, you get UL Solutions. As a global team of business and engineering experts, we develop software for a huge range of industries, including medical, sustainability, renewable energy and healthy buildings. Together, we’re dedicated to making a real-world difference, to using our knowledge for good and to pioneering positive change. Join our team and use your expertise to transform global safety, security and sustainability.