The Regulatory Affairs Leader - Pharma may be involved in Pre or Postmarket duties or both. He/she provides subject matter expertise and works with a team of RA professionals to ensure GEHC establishes best practices in premarket & postmarket for RA, and ensures accurate & optimal submission of regulatory medical product clearance files & postmarket reports that meet the requirements of the region or country. Essential Responsibilities • File / Maintain regulatory deliverables
• Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies
• Support local regulatory authority / notified body inspections as required
• Educate, train, & advise company professionals to ensure compliance with regulatory requirements
• Coach and mentor other RA professionals
• Create regulatory compliance / project plan with Product RA to ensure all requirements...cont.
- See more at: http://www.hirelifescience.com/regulatory-affairs-leader-pharma/marlborough-ma-11111-577270/?p=p&submission=2