Regulatory Affairs Specialist
Posted on: October 11, 2021
We are seeking a
Manager Regulatory Specialists (Remote) to support our
labs. Duties will include the following:
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
- Author and review
relevant sections of device regulatory submissions, as
collaboration with lab partners and internal teams, prepare for and
execute meetings with regulatory agencies.
- Develop/review new
regulatory policies, processes and SOPs.
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.
interactions with the US FDA a plus.
Keywords: Labcorp, Raleigh , Regulatory Affairs Specialist, Other , Raleigh, North Carolina
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