Senior/ Principal Regulatory Affairs Specialist - Marlborough

Only for registered members Marlborough, United States

4 weeks ago

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Job summary

This Senior/ Principal Regulatory Affairs Specialist will integrate with engineering and clinical teams to contribute to bench work design discussions early drafting of submissions This full-time permanent opportunity offers a competitive salary comprehensive benefits package qualified applicants must be willing , able to work on a w2 basis

Responsibilities

  • Act as technical regulatory partner collaborating with engineering R&D manufacturing clinical teams
  • Develop execute regulatory strategies pivotal trials IDE expansions commercialization pathways
  • Lead or contribute global submissions FDA Class II/III EU MDR Class I/IIb/III devices

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