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Principal Regulatory Affairs Specialist

  • Job type: Permanent
  • Location: San Diego
  • Salary: £120000 - £150000 per annum
  • Job reference: JEAO21218545
  • Sector: EPM Scientific, Regulatory
  • Date posted: 12/02/2018
Principal RA Specialist required for Global Medical Diagnostic Company
  • Principal Regulatory Affairs Specialist | IVD
  • Greater San Diego Area
  • $120,000 - $150,000 + excellent bonus + excellent benefits
A Global Medical Diagnostic Company, whose product lines involve clinical chemistry, coagulation, and enzymes, is actively seeking to speak with a highly motivated RA specialist to support the development and implementation of regulatory strategies of new and existing products. This company has received global recognition for their contributions to the Scientific community, as well as, their company culture and core values.

The Principal Regulatory Affairs Specialist will act as the lead RA liaison by overseeing all activities required to ensure manufactured products are in full compliance with internal and external regulations. This position is subject to managerial status down the line.

Responsibilities:
  • Review and approve product and manufacturing changes for compliance with applicable regulations
  • Develop and maintain company SOPs applicable to global regulatory requirements
  • Develop and implement regulatory strategies for new and modified products
Qualification:
  • BS in scientific or related field
  • 8+ years in Regulatory Affairs in Medical Device industry
  • 510k and PMA Submission experience highly desirable
  • IVD experience preferred
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