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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, with offices in 25 countries.

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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Business Development (US FDA) Manager – Austin, Texas

The Business Development Manager will work directly with Emergo Group's clients to:

  • Respond to new inquiries related to FDA regulatory pathway, 510(k), PMA, cGMP implementation/auditing/training inquiries
  • Meet with potential clients, either at Emergo Group’s offices, or onsite at the client’s offices
  • Create and send proposals for FDA services, helping to customize solutions to client’s specific needs
  • In coordination with VP of Business Development, assist to refine existing services with Emergo Group’s Consultants and Project Management
  • Stay updated on current regulations and expected changes and help to develop new services where opportunities exist
  • Initial focus will be on FDA related activities, which in future may be expanded to other markets

Skills and Experience required:

  • Five+ years experience in the medical device industry, in a sales or regulatory function
  • In-depth knowledge of US FDA regulations for medical devices
  • Good understanding of FDA Good Manufacturing Practices requirements
  • Strong client relationship building capability
  • Excellent verbal and written communications skills
  • Ability to think strategically with the client and understand the big picture
  • Strong attention to detail

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

  • Base salary and commission structure to commiserate with experience
  • Relocation compensation available for the right candidate
  • Health insurance premium reimbursement
  • Four weeks annual paid vacation
  • Contribution to 401(k) retirement plan
  • Disability insurance
  • A dynamic, enjoyable work environment

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

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Medical Device and IVD Regulatory Consultants

In the US and Europe we are seeking to fill positions for Regulatory Consultants who have at least 10 years of experience in a variety of therapeutic areas with technical file and design dossier compilations and FDA submissions, in particular 510(k)s and pre-IDEs. Ideally also with:

  • Regulatory IVD expertise
  • Experience with active devices
  • Experience with devices containing software

Please send your resume to careers [at] emergogroup [dot] com and let us know if you are interested in a full time position or working with us on a contract basis.

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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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