QA & RA Careers at Emergo Group

Emergo Group, Inc. is an ISO 9001:2008 and ISO 13485:2003 registered medical device consulting firm that serves medical device companies, particularly those that export their products abroad. We ensure that our clients are consistently in compliance by offering comprehensive, customized Quality Assurance and Regulatory Affairs solutions for all major markets worldwide.

The majority of our client base is comprised of small to medium-sized medical device manufacturers that are required to develop, implement and/or maintain quality assurance systems and register their devices in order to export their products.

Our home office is based in Austin, Texas, and is supported by 31 international offices. We enjoy a dynamic work environment and positive culture!

At Emergo Group, we are proud of our:

  • Emphasis on total customer satisfaction
  • Large and diverse domestic and international client base
  • Integrity in dealing with customers, vendors, associates and the community
  • High service standards
  • Management team’s international background and experience
  • ISO certification and regularly audited quality procedures

Why work for Emergo Group?

Emergo Group offers full-time employees a competitive compensation package that includes:

  • Solid base salary commensurate with experience
  • Medical insurance
  • Four weeks annual paid vacation
  • 401(k) retirement plan (US)
  • Disability insurance
  • A relaxed, enjoyable work environment
  • Plus additional benefits

Current Openings:

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Quality Assurance Consultant - Contract (USA and BENELUX)

POSITION SUMMARY: On a contractual basis the Quality Assurance consultant will work directly with Emergo Group's clients to:

  • Assist medical device manufacturers and suppliers in developing and implementing a quality management system for their specific needs and business practices for compliance with one or more of the following regulations:
    • FDA Quality System Regulations (QSRs)
    • ISO 13485 and ISO 9001 International Standards
    • European Medical Device Directives (Medical Device Directive (MDD), In Vitro Diagnostic Devices Directive (IVDD), Active Implantable Medical Device Directive (AIMDD)
    • Canadian Medical Devices Regulations (CMDR)
    • Japan's Pharmaceutical Affairs Law (PAL)
    • Other specific country regulations, as needed
  • Perform quality system assessments and audits for compliance with the FDA QSRs, ISO 13485 and ISO 9001 standard, CMDR, MDD, IVDD, AIMDD, Japan PAL and other specific country regulations.
  • Conduct supplier audits on behalf of customer’s according to their requirements
  • Provide training programs / sessions on quality and regulatory related topics
  • Provide Quality and Outsourcing / Ad Hoc consulting services which may include but are not limited to:
    • attending & assisting with audits
    • procedure development and training
    • maintenance and / or updating of their Quality Management System
  • Perform other quality and regulatory consulting services as needed by our clients and help customize consulting solutions to clients’ specific needs.

Skills and Experience required:

  • A minimum of five years’ experience in the medical device industry, in quality systems and/or a compliance-related function
  • Track record of successfully implemented and audited quality systems
  • Extensive knowledge of Medical Device industry regulatory requirements and experience in interactions with regulatory authorities
  • ISO 13485 processes and procedures
  • CE Marking, including European Medical Device Directive 93/42/EEC and 2007/47/EC
  • FDA Good Manufacturing Practices and QSR Part 820
  • Commitment to excellence in deliverables and customer service
  • Ability to anticipate and resolve issues
  • Excellent communication and time management skills
  • For this position, Emergo Group is seeking a consultant located in the US, and a second consultant located in the Benelux. This position will require regional and occasional international travel.
  • Relocation is not offered.

To Apply:
Please email your resume and cover letter to careers [at] emergogroup [dot] com. Please also indicate your salary requirements.

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Senior Regulatory Affairs Consultant – Contract (CANADA)

On a contractual basis the Senior Regulatory Affairs Consultant will work directly with Emergo Group's clients to:

  • Prepare Health Canada regulatory submissions (Class II, III and IV) for medical device and in vitro diagnostic devices
  • As required prepare US FDA 510(k) regulatory submissions
  • As required prepare CE Mark Technical Files
  • Represent the array of consulting services available to our clients and help customize consulting solutions to clients' specific needs.

Skills and Experience required:

  • A minimum of five years experience in the medical device industry, in a regulatory affairs related function preparing Health Canada submissions
  • Extensive knowledge of Medical Device industry regulatory requirements
  • Strong project management; client relations and written communications skills
  • Experience with CE Marking / Technical Files and 510(k) clearances
  • Experience with Health Canada Natural Health Products submissions would be an asset
  • A four-year college degree is required --OR-- minimum of 10 years working in the device industry.
  • Commitment to excellence in deliverables and customer service
  • Ability to anticipate and resolve issues
  • Ability to understand the big picture and at the same time be detail-oriented

Other Information:
Limited travel within the US/Canada or internationally may be required.

If you are interested in applying for this position, please send your curriculum vitae/resume to careerscanada [at] emergogroup [dot] com.

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Contracts Compliance Assistant (Austin - Downtown, TX USA)

The primary role of the position is to be the lead administrative assistant for the maintenance of annual contracts. A successful Assistant should be able to simultaneously manage a large volume of work, assist the team in creating and documenting annual contracts, follow up with staff to ensure established quality procedures are documented, understood and being executed.

Tasks/Responsibilities:
Support our Project Management teams with the following:

  • Interface between clients, consultants and other Emergo Group departments and international offices to successfully execute and maintain annual contracts.
  • Maintenance of accurate device and registration data
  • Support of client importation activities and maintenance of supporting documents.
  • Assist projects managers with the set-up of new projects
  • General support creating client reports and internal training materials.

Skills/Experience for Project Management team support

  • Strong attention to details and ability to follow procedures, processes and instructions Strong organizational skills
  • Ability to prioritize time-sensitive assignments
  • Strong communication and planning skills
  • Strong analytical and problem solving skills
  • Good time management skills
  • Works well under stress and with deadlines
  • Proficient with Microsoft Suite office especially Excel
  • Knowledge of SharePoint a plus

We offer a competitive compensation package that includes:

  • Annual starting salary in the low $30Ks, commensurate with qualifications and experience
  • Group Health insurance
  • Four weeks annual paid vacation
  • 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 to PMJobs [at] emergogroup [dot] com. Please also indicate your salary requirements.

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Global Regulatory Research Assistant (Austin - Downtown, TX USA)

Our Regulatory Affairs department is currently looking for an individual with great writing, editing and communication skills to support regulatory affairs consultants. The position requires various duties including regulatory research, report writing and application preparation.

This position, based at our Austin, TX office, provides a great opportunity to build a long-term career within the organization and has potential to move the individual into a Global Regulatory Affairs Associate position in a fairly short time. Relocation is not offered for this position.

Specific activities include:

  • Assist in preparation of medical device registration applications, as well as various other applications.
  • Perform regulatory research. This involves web searches, review of internal library, and other means.
  • Write regulatory reports. This involves summarizing technical and regulatory information in a narrative form.
  • Assist VP and Regulatory Specialists as needed.

We seek a candidate who possesses the following qualities:

  • Comfort with basic web technology.
  • 4 year degree in English, Education, Communication or equivalent work experience is preferred.
  • Excellent writing, editing and communication skills.
  • Strong customer service and problem solving skills.
  • 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.
  • Ability to take direction and execute designated tasks.
  • At least 2 years full time employment experience preferred.
  • Fluency in English.
  • Fluency in a foreign language is a plus.
  • Good computer skills.

To Apply:
Please email your resume and cover letter as Word attachments to RegJobs [at] emergogroup [dot] com. Please also indicate your salary requirements.

Emergo Group, Inc. is an Equal Opportunity Employer.

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Project and Client Support Assistant (Austin - Downtown, TX USA)

We are currently seeking Project and Client Support Assistants in our Austin office to assist with services for USA/EU, Mexico/Brazil, and Asia markets. In this position, candidates can build a solid foundation to help them grow professionally within the company, while gaining a valuable global experience.

Job Overview:
The primary role of the position is to help support clients and manage projects for the aforementioned markets. The majority of these projects are to assist our clients (medical device manufacturers) in obtaining regulatory approval to sell their devices in these markets and any relevant post-approval activities.

A successful Assistant should be able to simultaneously manage a large volume of work, generate clear and correct written and verbal communication, prioritize urgent tasks and become familiar with the regulations for medical devices in specific markets.

Specific activities include:

  • Interface between consultants, clients and other Emergo Group departments and international offices to successfully manage projects, deliverables, and compliance with quality expectations and deadlines
  • Provide information and advice to clients on the regulatory process for medical devices in the mentioned markets
  • Set-up and manage projects using several software platforms
  • Provide regulatory research, document management and document review
  • Coordinate calls and meetings between clients, sales/operations teams and regulatory specialists
  • Assist with lead and proposal follow up
  • Assist with the preparation of overviews, proposals, agreements and NDAs

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
  • Strong organizational skills
  • 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
  • 2 years related experience in project management or medical device industry preferred
  • Applicants must be currently authorized to work in the United States for any employer

What We Offer: We offer a competitive compensation package that includes:

  • Annual starting salary in the low to mid $30Ks, commensurate with qualifications and experience
  • Group Health insurance
  • Four weeks annual paid vacation
  • Contribution to 401(k) retirement plan
  • Disability insurance
  • A dynamic, international work environment and positive culture!

To Apply:
IMPORTANT: Please email your resume and cover letter as Word attachments to pmjobs [at] emergogroup [dot] com. Please also indicate your salary requirements.

Emergo Group, Inc. is an Equal Opportunity Employer.

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Senior Consultant, QA/RA (Brasília/São Paulo, BRAZIL)

The Quality Assurance and Regulatory Affairs consultant will work directly with Emergo Group's clients to:

  • Prepare ANVISA registration submissions (registro and cadastro) for medical devices
  • Assist manufacturers and suppliers in developing, implementing and maintaining quality system compliance programs and procedures in accordance with Brazil GMP
  • Perform quality system assessments for compliance with ANVISA regulations
  • Represent the array of consulting services available to our clients and help customize consulting solutions to clients' specific needs.

Skills and Experience required:

  • A minimum of five years experience in the medical device industry, in a regulatory affairs related function
  • Extensive knowledge of ANVISA Regulations and preparing registro and cadastro submissions
  • Brazil GMP processes and procedures
  • Strong project management; client relations and written communications skills
  • Experience with Technical Files and 510(k) clearances a plus
  • A four-year college degree is required --OR-- minimum of 7 years working in the device industry
  • Fluency in English and Portuguese
  • Commitment to excellence in deliverables and customer service
  • Ability to anticipate and resolve issues
  • Ability to understand the big picture and at the same time be detail-oriented

Other Information:
Must be willing to travel within Brazil and occasionally to international locations (including US).

If you are interested in applying for this position, please send your curriculum vitae/resume to pmjobs [at] emergogroup [dot] com.

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Senior Consultant, QA/RA (MEXICO)

The Quality Assurance and Regulatory Affairs consultant will work directly with Emergo Group's clients to:

  • Prepare COFEPRIS registration submissions for medical devices
  • Assist manufacturers and suppliers in developing, implementing and maintaining quality system compliance programs and procedures in accordance with GMP requirements
  • Perform quality system assessments for compliance with COFEPRIS regulations
  • Represent the array of consulting services available to our clients and help customize consulting solutions to clients' specific needs

Skills and Experience required:

  • A minimum of five years experience in the medical device industry, in a regulatory affairs related function
  • Extensive knowledge of COFEPRIS regulations and preparing registration submissions to COFEPRIS
  • Knowledge of GMP processes and procedures
  • Strong project management, client relations and written communications skills
  • Experience with Technical Files and 510(k) clearances a plus
  • A four-year college degree is required --OR-- minimum of 7 years working in the device industry
  • Fluency in English and Spanish
  • Commitment to excellence in deliverables and customer service
  • Ability to anticipate and resolve issues
  • Ability to understand the “big picture” and at the same time be detail-oriented

Other Information:

  • Must be willing to travel within Mexico and occasionally to international locations (including US)
  • Salary of MXN $20,000 per month, depending on experience

If you are interested in applying for this position, please send your curriculum vitae/resume to pmjobs [at] emergogroup [dot] com.

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