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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Business Development Assistant - Sales Group

The Business Development Assistant assists and reports to the Regional Manager. The Business Development Assistant serves as secondary support to their supervisor’s daily sales activities by creating proposals and communicating with clients to schedule meetings and obtain information for their supervisor and those in Business Development who need assistance.

Essential Responsibilities:

  • Prepare overviews, proposals, agreements and NDA to be sent out by Regional Manager/Account Manager
  • Coordinate sales calls and meetings between clients and Regional Manager
  • Answer phones for Business Development Department
  • Serve as point of client contact, response to requests for assistance and redirect as necessary
  • Use SalesForce to allocate and update data from web and phone leads throughout the day
  • Save client documents in SharePoint
  • Maintain up to date knowledge regarding global regulatory frameworks and their application to Emergo Group’s services and internal processes
  • Update internal Business Development regulatory documents and tools
  • Conduct timely lead and proposal follow up
  • Use SalesForce to ensure that web leads are followed up with by Regional Manager
  • Coordinate Regional Manager’s travel and travel schedule
  • Assist with tradeshow scheduling and pre-tradeshow notes

Qualifications:

  • Acts quickly and decisively with great organizational skills
  • Fast, accurate worker
  • Customer-service orientation
  • Positive attitude, team player
  • Strong business and work ethics

Please email your resume and cover letter as formatted PDF or Word document to recruiting [at] emergogroup [dot] com. Please also indicate your salary requirements.

Emergo Group, Inc. is an Equal Opportunity Employer.

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Account Manager - Sales Group

The Account Manager is responsible for supporting an outside sales manager and helping to achieve sales targets within a specified US region. Responsibilities include acting as the primary contact point for certain clients, strengthening relationships with existing clients to improve cross-selling results, assisting with key accounts and new prospective clients when requested, and mentoring sales assistants.

Essential Responsibilities:

  • Help to implement business plan to meet or exceed corporate objectives and sales goals in assigned geography
  • Provide management outlook and forecast
  • Utilize CRM to identify, develop, and close sales opportunities with targeted clients
  • Help achieve monthly, quarterly and annual sales targets for territory
  • Timely handling of projects whether performed personally or by other Emergo Group staff under supervision
  • Work closely with sales management and corporate staff to ensure coordination and cooperation in support of sales efforts
  • Develop and maintain an in depth technical knowledge of Emergo Group services and international regulatory systems/requirements
  • Provide feedback to business development teams on required support materials and new service development
  • Make Emergo Group the first choice for international regulatory assistance among medical device manufacturers in the territory
  • Drive account penetration strategies, and new customer identification strategies in assigned client accounts
  • Build and manage influential relationships with existing and potential clients
  • Perform other related duties as assigned

Qualifications:

Characteristics

  • Driven, motivated, and organized, with excellent verbal and presentation skills
  • Self-starter, positive attitude
  • Able to multi-task and deliver timely results
  • Strong attention to detail
  • Applies judgment and acts according to high standards of ethics and integrity

Skills

  • Strong sales acumen
  • Ability to think strategically with the client and understand the big picture
  • Understanding of lead generation / qualification and selling within a B2B environment
  • Ability to drive the sales process through completion, both independently and as part of a team
  • Ability to address all levels of client management, and to identify and influence decision makers
  • Understanding of companies operating in the medical devices space and current industry trends
  • Understanding of medical device regulations and QMS systems preferred
  • Software skills –MS Office, Excel, Outlook email, SalesForce.com

Experience

  • 4-year college degree (Bachelor of Science preferred)
  • 5+ years of healthcare industry experience (medical device sector preferred)
  • Demonstrated success in B2B sales (technical or professional services sales a plus)

To Apply:
Please email your resume and cover letter as formatted PDF or Word document to: recruiting [at] emergogroup [dot] com. Please also indicate your salary requirements.

Emergo Group, Inc. is an Equal Opportunity Employer.

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International Projects Assistant - 5 positions available

We have 3 positions available for the Mexico/Brazil markets, 1 position for the USA/EU markets and 1 position for the Asia Markets.

The primary role of this position is to help manage consultants and consulting projects in Emergo Group’s offices for the respective mentioned markets. The majority of these projects are to assist our clients (medical device manufacturers) in obtaining regulatory approval to market their devices in the mentioned markets.

A successful International Projects Assistant will be able to simultaneously manage a large volume of projects, generate clear and correct written and verbal communication, prioritize urgent tasks, and learn the regulations for medical devices in the mentioned 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
  • Communicate and resolve any issues pertaining to specific projects or to our entire client base
  • Provide support and training for Emergo Group’s regulatory consultants in the mentioned markets
  • Set-up and manage projects using software (Open Air, Sharepoint, MS Office, Salesforce)
  • Provide information and advice to clients on the regulatory process for medical devices in the mentioned markets

We seek a candidate who possesses the following qualities:

  • Excellent communication skills
  • 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

Note: Business communication (both verbal and written) in Spanish and/or Portuguese are desirable for candidates interested in applying for Mexico/Brazil markets.

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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Global Regulatory Research Assistant

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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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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