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Job

Senior Manager, Regulatory Affairs - Med Device

  • Location

    Los Angeles

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    17 days ago

  • Expiry date:

    2020-04-16

  • Startdate:

    ASAP

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