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  • Sunnyvale, CA

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Senior Manager Global Regulatory Affairs Strategy

Apple & Associates • Sunnyvale, CA

Posted 10 days ago

Job Snapshot

Travel - Up to 25%
Experience - At least 5 year(s)
Degree - 4 Year Degree
$135,000.00 - $190,000.00 /Year
+20% bonus and great benefits
Medical Equipment, Biotechnology, Pharmaceutical
Strategy - Planning, QA - Quality Control, Other
Relocation - Yes

Job Description

Senior Manager, Global Regulatory Affairs

One of the top Global Medical Device Companies has a new opening in Strategic Leadership of Regulatory Affairs!  As Senior Manager, Global Regulatory Affairs you will manage multiple projects within Regulatory Affairs, both domestically and internationally for class I and class II medical devices.  Use your extensive experience with medical devices including recently submitted 510k’s and completed Technical Files for the EU.  Leadership experience is essential as this role requires frequent presentations and communications with senior leaders in the organization.  

Senior Manager, Global Regulatory Affairs Responsibilities:

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.

Job Requirements

Senior Manager, Global Regulatory Affairs Requirements:

  • Bachelor degree in scientific discipline required or advanced degree with a minimum of 5 years of relevant experience
  • 7 years experience in Regulatory Affairs medical device arena 
  • 3+ years of managerial experience over direct reports
  • Demonstrated experience in preparing global regulatory submissions - PMAs, IVE's, 510(k), EUMDR experience a plus.
  • Experience authoring 510(k).
  • Management experience required/Exceptional leadership capabilities.
  • Strong interpersonal and analytical skills 
  • Excellent written and oral communication skills.
  • Excellent organizational and multi-project management skills.

Senior Manager, Global Regulatory Affairs Nice To Have:

  • Advanced Degree in Regulatory Affairs
  • EU MDR
  • RAC Certifiied
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