Regulatory Affairs Consultant

ESSENTIAL DUTIES AND RESPONSIBILITIES: 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 procedures. 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.

Qualifications: BS degree in Engineering, Physical or Biological science + a minimum of 4 - 6 years experience in Regulatory experience or advanced degree + 2 - 4 years experience in Regulatory Affairs. Required Knowledge, Skills, Abilities and Certifications/Licenses Must be familiar with MS Office applications Excellent communication skills (verbal and written)Project management skills Problem solving skills Presentation skillsRAC Certification preferred