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Careers at Emergo Group

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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.

INTERNATIONAL RA SPECIALIST- Austin, Texas or The Netherlands only

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

Specific Responsibilities:

  • Program management of Emergo Group's global medical device regulatory service programs, including in-country representation services for Europe, Japan, Australia, China and the US
  • 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 global regulatory compliance and/or quality assurance role.
  • Must have extensive knowledge of European Directives. Knowledge of Japanese, Chinese, Canadian and Australian regulations a plus.
  • 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

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.