Sr. Regulatory Compliance Specialist - Medical Dev – Mountain View

This position supports the quality of Boston Scientific's Embolic Protection medical device products.

Responsible for assessing and coordinating QA compliance activities to BSC and external standards by performing audits, Complaint & CAPA (Corrective and Preventive Action) functions, Environmental Monitoring activities, compiling metric reports, coordinating management review, and assist in the development and implementation of quality systems. Interface with Regulatory Agencies as needed.

Key Responsibilities:

• Manage CAPA system
  
• Backup for Complaints
  
• Manage implementation of corporate compliance objectives at site.
  
• Manage site compliance activities
  
• Quality Systems continuous improvement
  
• Interface with regulatory agencies.
  
• Assist and lead internal and external audit functions
  
  Qualifications:
  Ability to implement, manage and carry out projects to fruition. Proficient computer skills with applications such as Microsoft Office applications. Experienced in presentations and facilitating meeting. Good analytical skills. Good oral and written communications skills. At least 3 yrs+ with Medical Device Industry and some experience interfacing with regulatory bodies. Bachelor's degree preferred.
  
  Apply Here