Jon Lang Email & Phone Number

Boston, Ma, Us

Cambridge, Massachusetts, United States

Waltham, Ma

Waltham, Ma

Waltham, Ma

Waltham, Ma

Perform regulatory assessments and develop regulatory strategies for new devices or modifications to existing devices. Provide proactive guidance to project teams with a concise description of deliverables required for a successful submission. Critically review of all submission-related documents and provide constructive, balanced feedback to raise the quality of the submission and clarity of the submission ‘story’. Author Pre-Submissions and 510(k)s.

Responsible for the transition of new products from R & D to manufacturing through to commercial launch, e.g., scale-up, process development, validation, production documents, package design, etc.

Supervised activities of the Formulation and Filling Department ensuring operations were consistent with established procedures, customer requirements and cGMP guidelines. Responsible for formulation, processing and filling of blood gas, co-oximetry and bottled in-vitro diagnostic controls.

Medfield, Ma

Member of Quality Control department supporting the formulation and filling departments using a wide range of analytical techniques and equipment. Formulated reagents and blood gas controls used for Ciba-Corning, Chiron and Bayer point of care and clinical diagnostic analyzers.

Bs, Biology

Biology

International study

Medical Device Certificate Program– Regulatory Affairs

High School