ZipRecruiter

Log In

1

Fda Cber Jobs (NOW HIRING)

Globus Medical

Associate Project Engineer

Audubon, PA · On-site

Comprehensive knowledge of GMP, FDA, CBER, and CDRH regulatory requirements * Hands-on experience in process development, manufacturing, or quality systems for medical devices, biologics or ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · Hybrid

$162K - $213K/yr

Experience with major Health Authority interactionsincluding direct engagements with US FDA/CBER. * Hands-on leadership of IND and pre-IND CGT programs. * A solid knowledge of regulatory affairs ...

QuidelOrtho

Production Manager

Pompano Beach, FL

Ensure operations comply with QSR/GMP,FDA CBER, ISO standards, and other relevant medical device regulations. * Strategic Planning: Develop and execute plans for new product introductions (NPI ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · On-site +1

$162K - $213K/yr

Experience with major Health Authority interactions including direct engagements with US FDA/CBER. * Hands-on leadership of IND and pre-IND CGT programs. * A solid knowledge of regulatory affairs ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · On-site

$162K - $213K/yr

Experience with major Health Authority interactions including direct engagements with US FDA/CBER. * Hands-on leadership of IND and pre-IND CGT programs. * A solid knowledge of regulatory affairs ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · Hybrid

$162K - $213K/yr

Experience with major Health Authority interactions including direct engagements with US FDA/CBER. Hands-on leadership of IND and pre-IND CGT programs. A solid knowledge of regulatory affairs within ...

Stallergenes Greer

QA RELEASE TECHNICIAN

Lenoir, NC

Provides support for submissions to CBER for release by completing and reviewing the required ... Good working knowledge of current regulations including FDA, ICH, USP guidance. EOE, including ...

Exegenesis Bio Inc

Head of Regulatory Affairs

Ambler, PA · Remote

$153K - $202K/yr

... CBER * Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP guidelines and relevant requirements * A demonstrated ability to manage ...

Exegenesis Bio Inc

Head of Regulatory Affairs

Ambler, PA · Remote

$153K - $202K/yr

... CBER * Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP guidelines and relevant requirements * A demonstrated ability to manage ...

Hologic Inc.

Quality Engineer 3

San Diego, CA

$79K - $124K/yr

Regulatory requirements including FDA regulations (21 CFR Part 820, Part 11), ISO 13485, ISO 14971, and familiarity with CDRH and CBER expectations. Quality systems and electronic document management ...

next page

Showing results 1-20

People also search for

All JobsFda Cber Jobs

Fda Cber information

See salary details

$13

$52

$70

How much do fda cber jobs pay per hour?

As of Jun 6, 2026, the average hourly pay for fda cber in the United States is $52.19, according to ZipRecruiter salary data. Most workers in this role earn between $45.19 and $63.46 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Fda Cber position, and why are they important?

To thrive at FDA CBER (Center for Biologics Evaluation and Research), you need expertise in biological sciences, regulatory affairs, and data analysis, often supported by an advanced degree in a relevant scientific field. Familiarity with regulatory databases, clinical trial management systems, and guidance documents such as CFR Title 21 is crucial. Strong analytical, communication, and teamwork skills help you effectively evaluate product safety and efficacy while coordinating with diverse stakeholders. These abilities ensure that biologic products are rigorously reviewed for safety, quality, and compliance with federal regulations.

What are the typical daily responsibilities of someone working at FDA CBER?

Professionals at FDA CBER are usually involved in reviewing scientific data, assessing regulatory submissions for biologics, writing evaluation reports, and participating in team meetings to discuss product review findings. They commonly collaborate with scientists, physicians, and policy experts to ensure biologic products meet safety and efficacy standards. Day-to-day tasks may also include responding to inquiries from industry sponsors, developing policy guidance, and staying abreast of advances in biologic product development. This dynamic environment allows for constant learning and impact on public health through regulatory science.

What is an FDA CBER job?

An FDA CBER job refers to a position within the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). CBER regulates biological products, including vaccines, blood products, and gene therapies, to ensure their safety and effectiveness. Employees in CBER roles may work in regulatory affairs, scientific research, policy development, or compliance oversight. These positions typically require expertise in biology, medicine, or regulatory science.

More about Fda Cber jobs
What cities are hiring for Fda Cber jobs? Cities with the most Fda Cber job openings:
What states have the most Fda Cber jobs? States with the most job openings for Fda Cber jobs include:
What job categories do people searching Fda Cber jobs look for? The top searched job categories for Fda Cber jobs are:
Fda Cber jobs near you
Infographic showing various Fda Cber job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% Remote job distribution, with an average salary of $108,557 per year, or $52.2 per hour.
Associate Project Engineer

Associate Project Engineer

Globus Medical

Audubon, PA • On-site

Full-time

Posted 26 days ago

Globus Medical rating

6.7

Company rating: 6.7 out of 10

Based on 28 frontline employees who took The Breakroom Quiz

Job description

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Position Summary:
The Associate Project Engineer will offer technical support for the advancement of medical device and biologic products. This role entails conducting research and development, as well as sustaining engineering activities on launched products. Responsibilities include developing, optimizing, and validating medical devices/biologic products to uphold product quality standards as well as serving as a subject matter expert on commercialized offerings. Candidates must hold a Bachelor's or Master's degree in Biomedical Engineering, Biomedical Sciences, or a related field, with prior wet lab experience and industry experience strongly preferred.
Essential Functions:
  • Conducts development and maintenance activities for early stage and sustaining projects in the Regenerative Biologics Division portfolio, respectively
  • Designs and executes experimental protocols, collects and analyzes data, and provides comprehensive reports on findings
  • Maintains meticulous experimental records, drafts detailed technical reports, and ensures strict compliance with applicable quality and regulatory standards
  • Possesses in-depth knowledge of CBER (Center for Biologics Evaluation and Research) and CDRH (Center for Devices and Radiological Health) regulatory requirements for biologics and combination devices, ensuring full compliance with GMP standards in product development and manufacturing
  • Coordinates and oversees pre-clinical and biocompatibility studies, ensuring timely execution and regulatory alignment
  • Authors and reviews a variety of technical documents, including SOPs, protocols, regulatory submissions (IND, BLA), and scientific publications, ensuring clarity and accuracy
  • Stays updated on emerging trends and advancements in relevant technologies and actively contributes to innovation within the Regenerative Biologics Division
  • Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
  • Ensures compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
  • Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:
  • B.S. or M.S. in Biology, Biomedical Engineering, Biomedical Sciences, or a related field required
  • Exceptional communication and problem-solving skills required
  • Capable of independently managing project timelines and deliverables
  • Industry experience supporting medical devices as well as early-stage biologics or combination product development strongly preferred
  • Comprehensive knowledge of GMP, FDA, CBER, and CDRH regulatory requirements
  • Hands-on experience in process development, manufacturing, or quality systems for medical devices, biologics or combination products required
  • Solid understanding of stability studies, analytical characterization, and process validation
  • In-depth understanding of CMC (Chemistry, Manufacturing, and Controls) regulatory considerations
  • Strong organizational skills with demonstrated experience in documentation, data tracking, and regulatory compliance

Physical Demands:
The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Required to sit; climb or balance; and stoop, kneel, crouch or crawl
  • Required to regularly lift and/or move up to 25 pounds and occasionally lift and/or move up to 65 pounds
  • Required to possess specific visons abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus

Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
  • Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
  • Customer Focused: We listen to our customers' needs and respond with a sense of urgency.
  • Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
  • Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Equal Employment Opportunity:
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

What Globus Medical employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply