Pride Health
Senior Regulatory Affairs Specialist – PMA (IVD)
US Remote | W2 Contract
Do you enjoy rolling up your sleeves and owning PMA submissions from start to finish? Are you someone who actually likes authoring regulatory documents and collaborating with cross‑functional teams to get things done? If yes, this role is for you.
We’re looking for a
hands‑on Regulatory Affairs professional
with solid
FDA PMA experience in IVD medical devices
to join a remote team working on meaningful, high‑impact regulatory work.
What you’ll be working on:
Leading and supporting
end‑to‑end PMA submissions
for IVD medical devices
Authoring, drafting, and compiling PMA modules . This is a true hands‑on role, not coordination only
Working closely with teams across R&D, Clinical, Quality, and Manufacturing to gather inputs
Making sure submissions meet FDA requirements and expectations
Supporting FDA interactions, questions, and review cycles along the way
What will help you succeed:
5+ years of direct PMA experience
in Regulatory Affairs
Strong background in
IVD devices
Experience authoring PMAs for
Class III medical devices
Exposure to
tissue‑based diagnostics
is a nice‑to‑have
Clear, confident regulatory writing skills
Comfortable working independently in a fully remote setup
Role details at a glance
Pay rate:
$122.00‑$139.00 per hour (hourly, W2)
Hours:
40 hours per week
Schedule:
Monday to Friday, day shift (8:00 AM–5:00 PM)
Flexibility:
Schedule flexibility available when needed
Location:
US remote, Secaucus, NJ
Why you might like this role:
You’ll be doing
real PMA work , not just reviews or support tasks
Fully remote with a steady, predictable schedule
Opportunity to work on complex regulatory submissions that matter
Collaborative team that values ownership and expertise
If PMA work is your comfort zone and you’re looking for a flexible, remote contract with meaningful responsibility, we’d love to hear from you.
Seniority level Mid‑Senior level
Employment type Contract
Job function Health Care Provider
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US Remote | W2 Contract
Do you enjoy rolling up your sleeves and owning PMA submissions from start to finish? Are you someone who actually likes authoring regulatory documents and collaborating with cross‑functional teams to get things done? If yes, this role is for you.
We’re looking for a
hands‑on Regulatory Affairs professional
with solid
FDA PMA experience in IVD medical devices
to join a remote team working on meaningful, high‑impact regulatory work.
What you’ll be working on:
Leading and supporting
end‑to‑end PMA submissions
for IVD medical devices
Authoring, drafting, and compiling PMA modules . This is a true hands‑on role, not coordination only
Working closely with teams across R&D, Clinical, Quality, and Manufacturing to gather inputs
Making sure submissions meet FDA requirements and expectations
Supporting FDA interactions, questions, and review cycles along the way
What will help you succeed:
5+ years of direct PMA experience
in Regulatory Affairs
Strong background in
IVD devices
Experience authoring PMAs for
Class III medical devices
Exposure to
tissue‑based diagnostics
is a nice‑to‑have
Clear, confident regulatory writing skills
Comfortable working independently in a fully remote setup
Role details at a glance
Pay rate:
$122.00‑$139.00 per hour (hourly, W2)
Hours:
40 hours per week
Schedule:
Monday to Friday, day shift (8:00 AM–5:00 PM)
Flexibility:
Schedule flexibility available when needed
Location:
US remote, Secaucus, NJ
Why you might like this role:
You’ll be doing
real PMA work , not just reviews or support tasks
Fully remote with a steady, predictable schedule
Opportunity to work on complex regulatory submissions that matter
Collaborative team that values ownership and expertise
If PMA work is your comfort zone and you’re looking for a flexible, remote contract with meaningful responsibility, we’d love to hear from you.
Seniority level Mid‑Senior level
Employment type Contract
Job function Health Care Provider
#J-18808-Ljbffr