The Regulatory Affairs – Medical Device Team is looking for a Senior Manager, Regulatory Affairs, Med Device to develop and implement regulatory strategies and processes for medical devices and combination products.

Key Activities
 

• Responsible for the creation, implementation and maintenance of global regulatory strategies and plans.
• Direct and/or support global filing activities including team reviews prior to submission
• Review and approve device design control deliverables
• Create and support execution and maintenance of regulatory processes
• Direct internal review of policy for global regulatory guidance and regulations
• Identify and communicate relevant guidance, policies, standards, and regulations
• Create and maintain relationships with internal and external stakeholders

• May be required to perform regulatory review of labeling
• Review regulatory sections in development, quality, and supply agreements
• In charge of hiring and mentoring regulatory staff

Required:

6-8 years of  Regulatory Affairs, Life Sciences, Engineering related experience with appropriate degree

Preferred:
 

• 5-7 years  of experience working on United States and international medical device and/or combination product regulations
• 6-8 years of related experience in the medical device or combination product industry
• 1-3 years of direct managerial and/or leadership experience