Current positions available with Emergo

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:


Research Associate, Global Consulting

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 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

Administrative Assistant, Global Consulting

Emergo Group, Inc. 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 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 Suite office.

Business Development Assistant - Full Time

About Emergo :

Emergo is a leading global regulatory consulting company for medical device manufacturers. In 2017, Emergo was acquired by Underwriters Laboratory (UL). We maintain offices in 25 countries and assist companies with global regulatory strategy, device registration, quality management system compliance, and in-country regulatory representation.

About the Business Development Team :

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

Emergo is an Equal Opportunity Employer


Clinical Evaluation Reports Consultant - Contract (Telecommute)

We are currently seeking a contract consultant to compile Clinical Evaluation Reports (CERs) in compliance with MEDDEV 2.7/1 Rev. 4 guidance documents. The consultant will compile reports to define the performance and safety of medical devices as compared with benchmark devices, other devices and medical alternatives in the corresponding medical field. The consultant will interface with clients and Emergo employees and critically evaluate project progress and metrics. This is a contract position. Services will be engaged by Emergo on an hourly/project basis.

We are looking for candidates who can demonstrate the following skills:

  • Experience within the medical device industry and knowledge of clinical evaluation report requirements, EU regulatory affairs and risk management
  • Medical device writing experience
  • Experience conducting systematic literature reviews
  • Desired, though not required, ability to understand and interpret statistical results of clinical studies

Job Responsibilities:

  • Collate device information, post-market surveillance data and relevant clinical data
  • Systematically search citation databases for relevant literature
  • Assess literature, pre-clinical and clinical data, and post-market surveillance data
  • Identify and compare equivalent devices
  • Identify and define state of the art/current knowledge in medical fields corresponding with devices
  • Perform conformity assessments and compile findings and data collected in report template

Job Requirements:

  • BA or BS
  • Masters or PhD degree(s) in biomedical sciences or technical disciplines, preferred
  • Minimum of 2 years of work experience in the device industry
  • Medical and/or scientific writing within a medical device industry or related industry
  • Demonstrated competence in CER writing
  • Excellent analytical and communication skills, particularly writing skills, are essential.

To Apply:
Please email your resume and cover letter as Word attachments to recruiting@emergogroup.com.

Company Overview: Emergo Group, Inc. 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 in the Netherlands, Australia, Canada, Brazil, Mexico, UK, France, Germany, Russia, India, Korea, Japan, and China.

Emergo Group, Inc. is an Equal Opportunity Employer.

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Research Librarian/Literature Searcher - Contract (Austin, TX USA)

We are currently seeking a research librarian/literature searcher to perform systematic literature reviews for Clinical Evaluation Reports (CER). The librarian will support consultants in identification of academic journal articles reporting relevant clinical data on specified medical devices and treatment alternatives, and screen data in accordance with specified inclusion/exclusion criteria. This is a contract position. Services will be engaged by Emergo on an hourly/project basis.

We are looking for candidates who can demonstrate:

  • Knowledge of the medical device industry and CER regulatory requirements
  • Understanding of clinical research methodology and study design
  • Ability to interpret statistical results of clinical studies

Job Responsibilities:

  • Define literature search protocols and literature search queries
  • Execute literature searches in accordance with the search protocol
  • Screen titles, abstracts, and full text of publications from the literature search for clinical data on specified medical devices in accordance with inclusion/exclusion criteria set out in the literature search protocol
  • Collaborate with consultants to interpret and summarize clinical data from medical and scientific literature during the screening and data extraction steps of the systematic literature review process
  • Ensure documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7/1 Rev. 4), and electronic templates

Job Requirements:

  • BA or BS; masters of library sciences degree, preferred
  • Understanding of good data management practices and bibliographic software
  • 2 years of related work experience in the medical device industry, preferred
  • Demonstrated experience in regulatory compliance, preferred

To Apply:

Please email your resume and cover letter as Word attachments to recruiting@emergogroup.com.

Emergo Group, Inc. is an Equal Opportunity Employer.

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Medical Device Regulatory Compliance Medical Writer - Contract

We are currently seeking a medical device regulatory compliance medical writer to author Clinical Evaluation Reports (CERs). The regulatory compliance medical writer will author sections of reports describing the performance and safety of medical devices. This is a contract position. Services will be engaged by Emergo on an hourly/project basis.

We are looking for candidates who can demonstrate the following:

  • Ability to critically evaluate, analyze, and interpret medical literature for adequate study design, statistical significance, scientific rigor, and absence of bias
  • Experience conducting systematic literature reviews
  • Medical device industry writing experience
  • Record of maintaining timelines and completing assignments in timely manner

Job Responsibilities:

  • Collate device information, post-market surveillance data, and relevant clinical data
  • Systematically search vigilance and citation databases for relevant data/literature
  • Assess literature, pre-clinical and clinical data, and post-market surveillance data
  • Identify and compare benchmark devices
  • Identify and define state-of-the-art/current knowledge in medical fields corresponding with devices
  • Compile findings and data collected in report template

Job Requirements:

  • BA or BS
  • Masters or PhD degree(s) in biomedical sciences or technical disciplines, preferred  
  • Work experience in the device industry, preferred
  • Excellent analytical and communication skills, particularly writing skills, are essential.

To Apply:

Please email your resume and cover letter as Word attachments to recruiting@emergogroup.com.

Emergo Group, Inc. is an Equal Opportunity Employer.

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International Projects Coordinator (Austin, TX USA)

We are currently seeking Project Management professional to join our team in global headquarters in Austin, Texas. This position provides support services for domestic and international clients. In this position, candidates can build a solid foundation and grow professionally within the company, while gaining valuable global experience.

Job Responsibilities:

  • As assigned, serve as point of client contact for response to requests for assistance and manage deliverables for client accounts or redirect as necessary.
  • Lead account team to achieve deliverables on time and within budget
  • Interface between clients, consultants and other Emergo Group departments and international offices to successfully control and manage projects, their deliverables and comply with quality expectations and deadlines
  • Provide information and advice to clients on the regulatory process for medical devices in the mentioned markets
  • Utilize qualified resources, systems and financial tools to plan, staff, implement, control and evaluate each assigned project
  • Assist as liaison for Emergo Group consultants and critical suppliers, coordination of schedules, project calendar and availability tracking, assist with booking resources and timesheet management as assigned
  • Maintenance of secure and accurate client documentation.
  • Set-up and manage projects using several software platforms
  • Assist with maintenance of project-related procedures and communication of same to employees and contractors to ensure consistent practices.

JOB REQUIREMENTS

We seek a candidate who possesses the following qualities:

  • Excellent communication skills, both verbal and written
  • Strong customer service and problem solving skills
  • A minimum of 5 years of experience in project management, client services or medical device industry preferred
  • Strong organizational skills and comfortable learning multiple software programs
  • Ability to thrive in a fast-paced business environment, without the need for close supervision
  • Strong attention to details and ability to follow procedures, processes and instructions
  • A quick learner – and motivated to excel in this position
  • Applicants must have permanent authorization to work in the United States for any employer
  • Knowledge of major European languages a plus but not required

We offer a competitive compensation package that includes:

  • Salary commensurate with experience
  • Group Health insurance
  • A generous PTO allowance
  • Contribution to 401(k) retirement plan
  • Disability Insurance
  • A dynamic, international work environment and positive culture!

To Apply:
Please email your resume and cover letter as word attachments, along with your salary requirements to: pmjobs@emergogroup.com.

Emergo is an Equal Opportunity Employer.

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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: 0 – 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 email your resume/CV and cover letter, along with your salary requirements to: careers@emergogroup.com 

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Regulatory Affairs 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: 0 – 50%, depending on assignments 
Location: Although most positions will be home office based, preferred geographical locations are within the US and EU.

Objective:  To provide assistance to medical device manufacturing clients with developing regulatory strategies and obtaining premarket authorization for their products in key markets (primarily U.S., EU and Canada).

Medical Device experience is an important requisite. Specific experience with software and/or IVD s will be considered a plus.
 
Required technical and behavioral competencies:
Extensive knowledge of medical device regulatory requirements for US FDA and EU CE Marking per MDD and IVDD. 
Hands-on experience with EU Technical Files and knowledge of CE Marking requirements, Clinical Evaluation Report writing a plus.
Demonstrated experience with US 510(k) submissions, preferably with sole responsibility for completion.
Experience with other regulatory documents/submissions (US: 513(g), Pre-Sub, IDE; Canada: Class II-IV MDLs; EU: CERs).
 
Range of Expected Activities:
Research and advise on device classification and regulatory pathways and strategies.
Prepare and submit regulatory premarket submissions (510(k), technical files, Canada MDLs); communicate specific requirements for effective submissions. 
Assist in addressing and responding to deficiencies of product submissions identified by regulatory bodies.
Prepare meeting requests between clients and the FDA, and facilitate those meetings.
Interact and negotiate directly with regulatory authorities and notified bodies on behalf of clients.
Assist clients with other regulatory concerns, such as labeling, promotion, design change evaluation, etc.
Author CERs to support CE marking. 
Review documentation and advise clients in developing more effective documentation, e.g., risk management, labeling, reports.
 
In addition, the ideal consultant candidates will possess the following qualities:
Strong interpersonal skills and ability to work with all levels of a client’s organization.
Effective technical writing skills.
Ability to identify, understand and resolve issues. 
Professional, but friendly demeanor; diplomatic but assertive.
Detail oriented
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.
Ability to understand the big picture and is business-focused.
 
To Apply:
Medical Device experience is an important requisite. Specific experience with software and/or IVD s will be considered a plus. Please email your resume/CV and cover letter, along with your salary requirements to: careers@emergogroup.com 
 

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