Current positions available with Emergo

Company Overview:

Emergo by UL is an internationally-certified medical device consulting firm that serves medical device companies, particularly those that export their products abroad. Our home office is based in Austin, Texas, with international offices around the world.

We are currently accepting applications for the following open positions with Emergo. Before you apply, learn more about what it is like to work for Emergo by watching one of these short videos.

Current Openings:

Emergo is an Equal Opportunity Employer.


Research Associate, Global Consulting

We are currently seeking regulatory research support in our US headquarters in Austin, Texas, where our team provides a variety of services for domestic and international clients.

Job Overview:

The primary function of the position is to provide Research Associate support to the global consulting team. This involves supporting Emergo’s regulatory intelligence system (performing regulatory research and report writing), as well as providing administrative support to the Clinical Evaluation program.

Job Responsibilities include, but are not limited to:

  • Maintain document library. Monitoring websites for regulatory developments and keeping document library updated and current.
  • Perform regulatory research. This involves web searches, review of internal library and other means necessary to address an inquiry. Conduct research and assess informally translated information/documentation for markets in which content is not published in English.   
  • Write regulatory reports. This involves summarizing technical and regulatory information in a narrative form.
  • Complete peer reviews, proofreading, and document editing activities.
  • Draft communications to keep our clients informed of regulatory information.
  • Support the Clinical Evaluation Services program, assist with the operations of the program, and coordinate with other company departments as needed to complete associated tasks (project consultant assignment, quote coordination, etc.).
  • Act as the initial point of contact for administrative inquiries requested of or for the Clinical Evaluation services.  Support on-going and new hire training for Clinical Evaluation Services program.

Job Requirements:

  • Detail oriented and analytical
  • Strong research, comprehension, and writing skills
  • Good organizational skills
  • Strong communication and planning skills
  • Good time management skills

To apply, please send resume and cover letter to Aus.emergocareers@ul.com and specify "Research Associate" in the subject line.

 


 

Administrative Assistant, Global Consulting Department

We are currently seeking administrative support in our US Headquarters in Austin, Texas where our team provides a variety of services for domestic and international clients.

Job Overview:

The primary role of the position is to provide comprehensive administrative support to the global consulting team.

Job Responsibilities include, but are not limited to:

  • Act as the initial point of contact for general administrative inquiries requested of or for the global consultant group.
  • Support new hire onboarding of consultants globally; coordination with other company departments as needed to complete associated tasks.
  • Provide assistance to the group with the organization of training, tracking and certification materials.
  • Maintain inventory of consultant profile information, ensuring skills and professional credentials are accurately and thoroughly documented in our electronic systems.
  • Work with Global Resource Manager to conduct profile reviews for independent contract consultants.
  • Maintain current CVs for accuracy, readability and marketability, assist consulting group with any additional maintenance or follow up activities.
  • Coordinate team meetings, assist with agenda, minutes and follow up activities tracking
  • Provide data analysis support as needed.

Job Requirements:

  • Detail oriented and analytical
  • Strong organizational skills
  • Ability to prioritize time-sensitive assignments
  • Strong communication and planning skills
  • Good time management skills
  • Works well under stress and with deadlines
  • Ability to learn numerous new software programs quickly. Proficient with Microsoft Office Suite.

To apply, please send resume and cover letter to: Aus.emergocareers@ul.com and include "Global Consulting Assistant" in the subject line.


 

Business Development Assistant - Full Time

The Business Development Team has the first opportunity to impress companies when they contact Emergo for support with entering a new international market, providing regulatory training to their employees, or when the FDA showed up for an unannounced audit and it didn’t go too well. The BD Team determines what support the client really needs and educates them on the global regulatory landscape. We focus on customer satisfaction and help our clients reach their regulatory goals in the most efficient manner.

About the Position :

Emergo is currently seeking several highly motivated Business Development team members in our Austin office to join the team and support the day to day business development activities. An ideal candidate is a self-starter, hungry to learn, and has the drive to study global medical device regulations. Don’t worry, we don’t need you to become an expert, but you will need a good understanding of the services we offer and how the clients benefit from our services. You have likely not learned this in school so expect everything to be new and exciting.

Specific Responsibilities:

  • Answer inbound calls for the Business Development department
  • Create proposals and agreements
  • Follow up on proposals sent to potential clients
  • Follow up with companies who have expressed interest in Emergo’s services
  • Coordinate sales calls and meetings between clients and the Manager of Business Development
  • Obtain quotations and other information from international colleagues
  • Use SalesForce and SharePoint tools to maintain client and product information
  • Help create an enjoyable work environment

About You :

If you have strong organizational, oral and written communication skills, as well as attention to detail and an interest in learning about global regulations for medical devices, then you might be a great fit for the team. Microsoft Office is our main tool, so if you know how to use Outlook, Excel, Word, etc. well, you are already a step ahead. Priorities can change quickly and often clients want a response yesterday. To be successful, you need to be flexible, adaptable, and good at multi-tasking.

Specific Skills and Experience:

  • Strong attention to detail and ability to follow procedures, processes, and instructions
  • Impeccable communication (written and oral) and organizational skills
  • Ability to multi-task and prioritize in a fast paced environment
  • A quick learner - motivated to excel and provide more than expected
  • Excellent skills in MS Word, Excel, and Outlook; capacity to learn additional software
  • Excellent customer service and interpersonal skills
  • Flexible; able to accept new ideas and approaches
  • Able to work with little supervision and consistently contribute as a team player
  • SalesForce and SharePoint knowledge a plus
  • Applicants must be currently authorized to work in the United States for any employer
  • Fluent in Spanish and/or Portuguese a plus, but not a requirement

About The Application :

In 100 words or less, explain what interests you about this position and submit your resume.

About Benefits :

  • Group health, vision, and dental Insurance
  • Twenty-three (23) days annual paid time off
  • Contribution to 401(k) retirement plan
  • Group disability insurance and life insurance
  • A dynamic, international work environment and positive culture

To apply, please send resume and cover letter to BDJob@ul.com and include "Business Development Assistant" in the subject line.


Quality Assurance Consultants (US and EU)

Emergo is inviting applications from experienced, high caliber, medical device specialists with the following attributes:

Education:  Bachelor Degree required, preferably in area of life sciences, medical, or engineering
Experience: At least 5 years in a quality assurance or regulatory affairs role; consultant experience preferred
Travel: 50%, depending on assignments 
Location: Although most positions will be home office based, preferred geographical locations are within the US and EU.

Medical Device experience is an important requisite. Specific experience with software and/or IVD s will be considered a plus. Successful candidates will demonstrate the qualifications and competency to support the following areas of medical device consulting:
 
Objective: To provide assistance to our medical device manufacturing clients with developing, implementing quality management systems, policies, and procedures to ensure that the performance and quality of their products conform to established standards and agency regulations.

Required technical and behavioral competencies: 
• A demonstrated knowledge and understanding of medical device quality system requirements (FDA QSR, ISO 13485, CMDR, MDD, MDSAP) 
• CQE, CQA or other quality certification preferred.

Range of Expected Activities:
• Support device manufacturers and suppliers with developing, implementing, and maintaining a quality system in compliance with applicable internal, domestic and international regulations, including but not limited to US 21 CFR 820 (QSR), ISO 13485, CMDR, MDD, etc.
• Assist clients in identifying and resolving nonconformances / implementing CAPAs to ensure products are manufactured in compliance with the quality management system.
• Conduct internal audits, inspection preparedness audits, supplier audits for compliance to relevant US and international regulations, particularly to the above-mentioned standards, delivering comprehensive audit reports.
• Provide training programs to clients on quality system requirements, including management responsibility.

To apply, please send resume and cover letter to EmergoConsultingCareers@ul.com and specify "Quality Assurance Consulting" in the subject line.

 


Regulatory Operations Coordinator (US)

The Regulatory Operations team, based in Emergo’s Austin TX headquarters, supports our Representation clients in Europe, Australia, New Zealand, and Israel. Each team member assists with ongoing regulatory activities for an individual set of clients, and we prioritize customized support to maintain long-term professional relationships.

This is a relatively small group within the company, and our service is central to the organization’s global reach. Ideal candidates for this position enjoy continual learning, collaborating with an array of international colleagues and providing high quality client support. Previous medical device or regulatory knowledge isn’t necessary. We will provide ground-up training for the right candidate.

Job Overview:

The primary role of the position is to provide support to medical device manufacturers who sell in countries where they do not maintain a physical office. We liaise with in-country Regulators to facilitate compliance with local medical device requirements. This includes answering questions about the local regulations, completing notifications to Regulators for low-risk devices, and ensuring Emergo receives the information it’s required to maintain from its clients. Questions and registrations that require expert involvement from a Regulatory Consultant will be project managed by the Regulatory Operations Coordinator.

Job Responsibilities include, but are not limited to:

  • Maintain customer service relationships with global clients
  • Act as the primary point of contact for market-specific regulatory inquiries
  • Recruit consultant resources for research and guidance as necessary
  • Communicate project status to clients clearly and concisely on a regular basis
  • Implement project procedures and document adherence to internal processes, including:
    • Track clients in project management software
    • Collect and archive technical information
    • Invoice and maintain customer contracts
    • Complete notifications to Ministries of Health
    • Obtain certificates from government agencies upon client request
  • Collaborate with Business Development, Project Management, and Accounting teams to streamline client experience

Job Requirements:

  • Detail oriented and analytical
  • Strong organizational skills
  • Ability to prioritize time-sensitive assignments
  • Strong communication and planning skills
  • Works well under stress and with deadlines
  • Ability to learn numerous new software programs quickly
  • Receptive to feedback and willing to engage colleagues to support learning

To Apply:

Please submit your Cover Letter and Resume to AUS.EmergoCareers@ul.com and specify “Regulatory Operations Coordinator” in the Subject Line.

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