Regulatory Affairs Leader - Pharma job in Marlborough, MA

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Matthew Masterson
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Regulatory Affairs Leader - Pharma job in Marlborough, MA

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. 
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