ZipRecruiter

Log In

1

Fda Cdrh Jobs (NOW HIRING)

Tunnell Government Services

Ophthalmology SME

Bethesda, MD · On-site

$20 - $27/hr

FDA CDRH - Ophthalmology SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and ...

Tunnell Government Services

Ophthalmology SME

Washington, DC

$21.25 - $28.50/hr

FDA CDRH - Ophthalmology SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and ...

Tunnell Government Services

Urology SME

Bethesda, MD · On-site

FDA CDRH - Urology SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and ...

Tunnell Government Services

Ophthalmology SME

Bethesda, MD · On-site

$20 - $27/hr

FDA CDRH - Ophthalmology SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and ...

Tunnell Government Services

Ophthalmology SME

Bethesda, MD · On-site

$20 - $27/hr

FDA CDRH - Ophthalmology SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and ...

next page

Showing results 1-20

People also search for

All JobsFda Cdrh Jobs

Fda Cdrh information

See salary details

$13

$39

$76

How much do fda cdrh jobs pay per hour?

As of May 29, 2026, the average hourly pay for fda cdrh in the United States is $39.35, according to ZipRecruiter salary data. Most workers in this role earn between $24.52 and $49.04 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an FDA CDRH (Center for Devices and Radiological Health) professional, and why are they important?

To thrive as an FDA CDRH professional, you need a background in biomedical engineering, life sciences, or a related field, often with advanced degrees and experience in regulatory affairs. Familiarity with regulatory submission systems (like eSTAR, eCopy), FDA guidance documents, and certifications such as RAC (Regulatory Affairs Certification) are typically important. Strong analytical skills, attention to detail, and clear communication are essential for evaluating medical device safety and efficacy and collaborating across teams. These competencies ensure compliance, protect public health, and support the timely approval of safe and effective medical devices.

What types of cross-functional collaboration can I expect in an FDA CDRH role?

In an FDA Center for Devices and Radiological Health (CDRH) position, you'll frequently work with multidisciplinary teams, including scientists, engineers, medical officers, and regulatory specialists. Collaboration is essential for reviewing medical device submissions, conducting safety evaluations, and developing regulatory policies. You'll often participate in meetings, share findings, and contribute your expertise to ensure that devices meet federal safety and efficacy standards. This collaborative approach not only enriches your own knowledge but also ensures comprehensive oversight of medical devices.

What is the FDA CDRH?

The FDA CDRH stands for the Center for Devices and Radiological Health, which is a branch of the U.S. Food and Drug Administration. Its primary role is to ensure the safety and effectiveness of medical devices and radiation-emitting electronic products in the United States. The CDRH oversees the premarket approval process, monitors postmarket performance, and enforces regulations to protect public health. It also provides guidance to manufacturers, healthcare professionals, and consumers regarding medical devices and their safe use.

What is the difference between Fda Cdrh vs Fda Cdrh?

AspectFda Cdrh

Since the comparison is between the same job title, Fda Cdrh vs Fda Cdrh, there is no difference. Both roles involve regulatory oversight of medical devices, require similar certifications, and are employed within the FDA's Center for Devices and Radiological Health. The responsibilities, work environment, and industry usage are identical, making them essentially the same position.

More about Fda Cdrh jobs
What cities are hiring for Fda Cdrh jobs? Cities with the most Fda Cdrh job openings:
What states have the most Fda Cdrh jobs? States with the most job openings for Fda Cdrh jobs include:
What job categories do people searching Fda Cdrh jobs look for? The top searched job categories for Fda Cdrh jobs are:
Fda Cdrh jobs near you
Infographic showing various Fda Cdrh job openings in the United States as of May 2026, with employment types broken down into 82% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 100% Hybrid job distribution, with an average salary of $81,843 per year, or $39.3 per hour.
Associate Director / Director, Regulatory Affairs - IHC Companion Diagnostics (CDx)

Associate Director / Director, Regulatory Affairs - IHC Companion Diagnostics (CDx)

SystImmune, Inc

Redmond, WA • On-site

$150K - $230K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 27 days ago

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
We are seeking a Regulatory Affairs leader at the Associate Director or Director level to lead IHC-based Companion Diagnostics (CDx) regulatory strategy and execution in support of our oncology ADC pipeline. This role will serve as the regulatory authority for CDx programs, with direct FDA CDRH engagement, and will build and lead a growing CDx Regulatory team over time.
The successful candidate will set regulatory direction, guide cross-functional teams, and ensure high-quality IDE and PMA submissions, while remaining sufficiently hands-on to provide technical oversight and mentorship when needed. This position reports directly to the Head of CDx and is a core leadership role in the CDx organization.
Key Responsibilities
CDx Regulatory Leadership
  • Lead US regulatory strategy for IHC-based Companion Diagnostics across multiple oncology programs
  • Serve as the regulatory decision-maker for CDx development, submissions, and FDA engagement
  • Establish CDx regulatory best practices, processes, and governance within the organization
FDA CDRH Engagement & Representation
  • Act as the senior regulatory representative to FDA CDRH for IHC CDx programs
  • Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional level
  • Guide preparation of FDA briefing packages and responses, ensuring scientific and regulatory consistency
Team Building & People Leadership
  • Build, mentor, and lead a CDx Regulatory Affairs team, with direct reports added over time
  • Set expectations, review work quality, and develop regulatory talent within the CDx organization
  • Provide regulatory leadership and mentorship to cross-functional partners and junior team members
Cross-Functional & External Leadership
  • Partner with Drug Regulatory (CDER), Clinical Development, Biomarker, Pathology, and QA leaders to ensure aligned drug-diagnostic co-development
  • Lead regulatory coordination with external diagnostic partners, CROs, and central laboratories
  • Represent CDx Regulatory perspectives in senior cross-functional and program governance meetings
Submission Oversight & Quality
  • Provide leadership oversight for IDE, PMA, and PMA supplement submissions for IHC CDx
  • Ensure analytical and clinical performance strategies (including scoring and cutoff rationale) meet FDA expectations
  • Maintain high regulatory quality standards while enabling efficient execution
Risk Management & Readiness
  • Identify and proactively manage regulatory risks related to IHC assay performance, interpretation, and transfer
  • Support inspection readiness and regulatory compliance for CDx partners and internal processes
  • Monitor evolving FDA CDx and IHC-related guidance and assess impact on portfolio strategy

Qualifications
  • Bachelor's degree or higher in Life Sciences, Pathology, Molecular Biology, or related field
  • 8+ years (Associate Director) or 10+ years (Director) of regulatory affairs experience in IVD/CDx
  • Demonstrated experience leading FDA CDRH interactions for Companion Diagnostics
  • Strong background in IHC-based CDx development, including understanding of scoring systems and clinical cutoffs
  • Proven ability to lead cross-functional teams and influence without authority

Preferred
  • Prior experience managing or building regulatory teams
  • Oncology CDx experience supporting patient selection strategies
  • Experience working with automated IHC platforms and external diagnostic partners
  • Familiarity with global CDx regulations (EU IVDR, China NMPA)

Leadership Competencies
  • Strategic decision-making with execution awareness
  • Clear, confident FDA-facing communication
  • Ability to develop people and build scalable regulatory functions
  • Strong judgment balancing regulatory rigor with program timelines

Compensation and Benefits:
The expected base salary range for this position is $150,000 - $230,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Apply