Careers at Emergo Group

Emergo Group, Inc. is an established ISO registered consulting firm that primarily serves medical device and IVD companies. The majority of our client base is comprised of small to medium-sized medical device and IVD manufacturers that are required to meet specific regulatory requirements in order to sell their products worldwide. Our world headquarters is located in Austin, Texas and we maintain addtional offices in Australia, Canada, China, Japan and The Netherlands.

Current openings at Emergo Group

RA Specialist - Austin, Texas USA only or The Netherlands only
Senior QA/RA Consultant - Most major US or Western European cities

REGULATORY AFFAIRS SPECIALIST- Austin, TX only

The RA Specialist will provide ongoing assistance with regulatory compliance and/or quality assurance issues for Emergo's medical device and IVD clients.

Specific Responsibilities:

• Program management of Emergo Group's medical device regulatory service programs, including Authorized Representation for Europe
• Handle client inquiries and provide phone consultation regarding medical device quality assurance and regulatory compliance issues from Emergo's client base of several hundred medical device companies
• Prepare FDA 510k applications and compile/review Technical Files for CE Marking
• Coordination of client Incident Reporting/Adverse Events
• Update and maintain client files

Required Skills and Experience:

• 3+ years of experience in the medical device sector in a regulatory compliance and/or quality assurance role.
• Must have extensive knowledge of CE Marking and the Medical Device Directives
• Must have experience with FDA 510k and Technical File preparation.
• Developed multitasking and project management skills.
• Detailed oriented. Must be able to succeed with little supervision.
• Experience with Incident Reporting/Adverse Events and recalls.
• Experience with implementation and maintenance of quality systems (ISO 13485 and FDA GMP).
• International experience and understanding preferred.
• RAC designation a plus.
• Good computer and skills; inclination to adopt technology to maximize efficiency.
• First-rate written communications skills. Excellent customer service and telephone skills.
• Strong attention to detail and follow through.
• Ability to deal with problems/issues in a mature and professional manner.
• Consistently contribute as a team player. Flexible; able to accept new ideas and approaches.
• Foreign languages a plus, but not required. Fluency in English mandatory.
  
• Travel less than 10%. Position based in Austin, Texas or The Netherlands
  

SENIOR QA/RA CONSULTANT - Any major US or Western European city

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

• Assist manufacturers and suppliers in developing, implementing and maintaining quality system compliance programs and procedures in accordance with ISO 13485; FDA cGMP; and CMDR
• Perform quality system assessments for compliance with FDA regulations, ISO 13485, European Union Directives and Health Canada requirements.
• 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 quality systems / compliance-related function
• Must be certified RAB-approved Lead Auditor
• Extensive knowledge of Medical Device industry regulatory requirements
• ISO 13485 processes and procedures
• CE Marking, including European Medical Device Directive 93/42/EEC and 2007/47/EC (knowledge of In-Vitro Diagnostics helpful)
• FDA Good Manufacturing Practices and QSR Part 820
• Canadian medical device requirements (desireable, not required)
  
• Track record of successfully implemented and audited ISO quality systems
• Strong project management; client relations and written communications skills
• Experience with Technical Files and 510(k) clearances desirable
• 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:

Must be willing to travel within the US/Canada or Internationally up to 80%. Consultant can work from any U.S. or Western European city within a 90 minute drive of a major airport. Preferred locations: northeast/southeast/western US, or in Germany, Netherlands, UK, or France. Other locations considered.

Why work for Emergo?

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 addtional benefits
  

We prefer that you email your resume to us in Word or PDF format using the email address below.