Design Control for the Development of Medical Device and Device Combination Products

  • Anywhere

Lachman Consultants

Lachman Consultants is in need of experts in the field of Design Control for the development of Medical Device and Drug/Device Combination products who are willing to work on a per diem basis.  Must have demonstrable, hands-on experience in the following areas:

  • Development, submission and commercialization of medical device / combination products
  • Design control / design requirements / design documentation
  • Design verification planning / design validation
  • Clinical studies / clinical trials
  • Quality systems / quality assurance / quality standards
  • Applicable GMPs / GLPs / guidances and regulations
  • Risk assessment process / application
  • Testing requirements
  • Human factors studies
  • Standard Operating Procedure development / reviews
  • Pre-marketing requirements, activities, regulations and guidances
  • Post-market reviews, considerations, safety reporting, regulations and guidances
  • Design History files
  • Training

Consultants must have a minimum of a Bachelor’s degree in life sciences, engineering or related field and 10 years’ related experience, as well as detailed knowledge of current FDA regulations and expectations. Preference will be given to candidates that possess EE/ME degree(s) or experience as well as the required skills listed above. Strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate importance of issues and prioritize accordingly. If you meet all of the qualifications, please submit your full chronological resume via the Lachman website or to recruitment@lachmanconsultants.com. No phone calls please. Thank you.

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