Sr RA Specialist : Medical Domain (8742)
:Develop and implement regulatory strategies and processes to ensure timely global
commercialization of products in compliance with applicable regulations and standards.
: Author regulatory submissions and assessments for class II and III medical devices to be distributed
in the US to ensure timely global commercialization of products in compliance with applicable
regulations and standards.
:Author technical files and design dossiers for products to be distributed in the EU.
:Prepare international documentation to support product registration internationally.
:Directly communicate with FDA and other Regulatory agencies in preparing responses to
submissions and in support of agency audits.
:Evaluate proposed changes to product design or manufacturing processes and assess impact of
the proposed changes with regard to worldwide approvals and internal BWI policies and
:Participate on new product development teams.
:Review and approve new product development and product modification documentation.
:Write, review and revise company SOPs as required.
:Communicate business related issues or opportunities to next management level.
: Ensure personal and Company compliance with all Federal, State, local and Company regulations,
policies, and procedures.
:Perform other duties assigned as needed.
:BS degree in Engineering, Physical or Biological science a minimum of 4 years experience in
:Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries or
advanced degree 2 years experience in Regulatory Affairs or other related discipline in the medical
device or pharmaceutical industries
:Must be familiar with MS Office applications
: Excellent communication skills (verbal and written)
: Project management skills
: Problem solving skills
: Presentation skills
: RAC Certification preferred