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Regulatory Affairs Specialist

Company: Labcorp
Location: Raleigh
Posted on: October 11, 2021

Job Description:

Job Overview:

We are seeking a Manager Regulatory Specialists (Remote)  to support our labs.  Duties will include the following:

  •  
  • Support implementation and execution of CDX strategy in collaboration with internal teams and external partners and ensure that the development timelines, regulatory pathways and commercialization plans are coordinated.
  • Provide guidance to the teams on the regulatory requirements supporting CDx submissions to US FDA, EU and other health authorities globally and ensures that all regulatory submissions are planned, communicated and executed per regulatory and business requirements.
  • Collaborate with lab partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions.
  • Author and review relevant sections of device regulatory submissions, as appropriate.
  • In collaboration with lab partners and internal teams, prepare for and execute meetings with regulatory agencies.
  • Develop/review new regulatory policies, processes and SOPs.

Education/Qualifications:

Bachelors degree.

Experience:

  • 1+  years’ regulatory experience in medical devices with at least 1-2 years in IVDs.
  • Excellent written and verbal communication skills.
  • Must have experience with medical device submissions including pre-submissions, IDEs, 510(k)s. Experience with HDE/PMA submissions is a plus but not required.
  • Previous interactions with the US FDA a plus.

Keywords: Labcorp, Raleigh , Regulatory Affairs Specialist, Other , Raleigh, North Carolina

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