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QA & RA Careers at Emergo Group

Emergo Group, Inc. is an ISO 9001:2008 registered consulting firm that serves the medical device sector. We ensure our clients' compliance by offering comprehensive, customized Quality Assurance and Regulatory Affairs solutions. 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 ISO Quality Assurance Systems in order to export their products. We have offices in Austin, Texas, The Netherlands, France, Germany, UK, Australia, Canada, China, Japan, Russia, Mexico, and Brazil.

Current Openings:

 

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 experience with IVDs, active devices and 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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International Projects Coordinator

Emergo Group, Inc. is an ISO 9001:2008 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 international offices in The Netherlands, Australia, Canada, Brazil, Mexico, UK, France, Germany, Russia, India, Korea, Japan and China.

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

Job Description:

Our Project Management department is currently looking for an individual with great organizational skills to provide coordination support between Emergo Group’s large client base, international business development team, and global offices. This position, based at our Austin, TX office, provides a great opportunity to build a long term career within the organization.

Specific activities include:

  • Administrative project management assistance for North American and/or international clients.
  • Interface with internal offices and departments with regards to project resourcing, billing, status updates and account follow up activities.
  • Communication with clients with regards to project support and monitoring, invoicing, deliverables and post-delivery support.
  • Utilization of qualified resources, systems and financial tools to Plan, Staff, Implement, Control and Evaluate each assigned project.
  • Liaison with regulatory and quality assurance professionals to provide systems and communication support within the scope of individual projects.
  • Maintenance of secure and accurate client documentation.
  • Serve as secondary support to help answer general incoming calls from clients, prospects, sales people and service providers in a professional manner.

We seek a candidate who possesses the following qualities:

  • Excellent communication skills - both verbal and written
  • 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
  • 2 years related experience in project management or medical device industry preferred
  • Note: a working knowledge of Spanish, Chinese, or other foreign language is a plus.

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

  • Gross annual starting salary in the low to mid $30K range, commensurate with qualifications and experience
  • Health insurance premium reimbursement
  • Four weeks annual paid vacation
  • Contribution to 401(k) retirement plan
  • Disability insurance
  • A relaxed, enjoyable work environment

To Apply:

Please email your resume and cover letter as Word attachments to pmjobs [at] emergogroup [dot] com (subject: International%20Projects%20Coordinator%20Position) . Please also indicate your salary requirements.

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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

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