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Project Manager, Regulatory Affairs

  • Job type: Permanent
  • Location: Fremont
  • Salary: £120000 - £140000 per annum
  • Job reference: JEAO2718536
  • Sector: EPM Scientific, Regulatory
  • Date posted: 07/02/2018
Project Manager, RA for Global Medical Device & Equipment Manufacturing Company
  • Project Manager, Regulatory Affairs | Medical Device
  • Greater San Francisco Bay Area
  • $120,000 - $140,000 + excellent bonus + excellent benefits
A world leading Medical Technology Company, that offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine, is actively looking to hire a strategic RA liaison to offer leadership, and organization for the Neurovascular global regulatory division.

The Project Manager, RA will act as the forefront for global regulatory strategies and submissions required to support integral product launches and ongoing market access.

Responsibilities:
  • Assure the strategic plan for the company’s new and sustaining product assortment is established, executed, and maintained globally on a pre and post-market basis
  • Work with project teams and management to execute the strategic plan
  • Provide regulatory guidance and strategic direction to accelerate product development and process improvement
 Qualifications:
  • BS or Advanced degree in a related field
  • 7+ years’ experience in an FDA regulated Medical Device field
  • 2+ years PM experience in (RA, R&D, or Ops)
  • Knowledge of Quality Systems (21 CFR)
 

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