Quality & Regulatory Affairs Consultant

UL, LLC; Los Morales Sección Palmas; Sur place; MXN 520 000 - 800 000; Plein temps

Résumé du poste

UL Solutions is seeking a Quality and Regulatory Affairs Consultant to support global regulatory submissions for medical devices and liaise with consulting partners and authorities as needed.

You will assist with registrations, renewals, amendments, and document reviews, while escalating complex issues to senior experts and delivering regulatory reports to clients.

Qualifications

• Bachelor's degree in a Medical, Engineering or Science field is preferred.
• Advanced, professional-level written and verbal English and excellent communication skills.
• Generally, 2–5 years of Quality Assurance and/or Regulatory Affairs experience in medical devices.

Responsabilités

• Assist with submission of medical device registrations/licensing applications to regulatory markets.
• Prepare renewals and amendments and support project teams; may involve direct client interaction.
• Develop knowledge of regulatory requirements and submission processes; guide clients through phases.
• Assist with client documentation reviews and gap analyses to satisfy submission requirements.
• Escalate complex regulatory issues to senior experts and follow through to resolution.
• Prepare regulatory reports and provide consultation on quality assurance and regulatory compliance.
• Act as regulatory support on large consulting project teams with multiple stakeholders.
• Liaise with local regulatory authorities on behalf of clients where appropriate.

Connaissances

Advanced English

Excellent communication

Attention to detail

Multitasking

Organization

Prioritization

Formation

Bachelor's degree in Medical, Engineering or Science

Outils

Microsoft Office

Description du poste

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.

• 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.

• 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.

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.

UL LLC has been and will continue to be an equal opportunity employer. To assure full implementation of this equal employment policy, we will take steps to assure that:

Persons are recruited, hired, assigned and promoted without regard to race, color, age, sex or gender, sexual orientation, gender identity, gender expression, transgender status, religion, creed, national origin, ethnicity, citizenship, ancestry, disability, genetic information, military or veteran status, pregnancy, marital or familial status, or any other protected category under applicable law.