In this Regulatory Specialist role, you'll play a critical part in bringing transformative ... Play a hands-on role in FDA submissions for breakthrough Class II and III medical devices * Enjoy a ...
In this Regulatory Specialist role, you'll play a critical part in bringing transformative ... Play a hands-on role in FDA submissions for breakthrough Class II and III medical devices * Enjoy a ...
Clinical SME I
Herndon, VA · Remote
Provide guidance on FDA regulatory requirements and ICH guidelines. * Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and ...
Clinical SME I
Herndon, VA · Remote
Provide guidance on FDA regulatory requirements and ICH guidelines. * Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and ...
Provide end-to-end regulatory guidance for FDA SaMD submissions (510(k), De Novo, Pre-Sub, etc.) * Develop and review documentation including: * SaMD Risk Analysis (ISO 14971) * Clinical Evaluation ...
Provide end-to-end regulatory guidance for FDA SaMD submissions (510(k), De Novo, Pre-Sub, etc.) * Develop and review documentation including: * SaMD Risk Analysis (ISO 14971) * Clinical Evaluation ...
Clinical SME I
Herndon, VA · Remote
Provide guidance on FDA regulatory requirements and ICH guidelines. * Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and ...
Quick apply
Clinical SME I
Herndon, VA · Remote
Provide guidance on FDA regulatory requirements and ICH guidelines. * Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and ...
Clinical SME I
Herndon, VA · On-site
Provide guidance on FDA regulatory requirements and ICH guidelines. * Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and ...
Clinical SME I
Herndon, VA · On-site
Provide guidance on FDA regulatory requirements and ICH guidelines. * Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and ...
Clinical SME I
Herndon, VA · Remote
Provide guidance on FDA regulatory requirements and ICH guidelines. * Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and ...
Clinical SME I
Herndon, VA · Remote
Provide guidance on FDA regulatory requirements and ICH guidelines. * Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and ...
Regulatory Assistant
Hialeah, FL · On-site
$20 - $25/hr
This role assists in maintaining adherence to ICH-GCP guidelines, FDA regulations, IRB requirements, and sponsor protocols, while contributing to audit readiness and overall site quality. Key ...
Quick apply
Regulatory Assistant
Hialeah, FL · On-site
$20 - $25/hr
This role assists in maintaining adherence to ICH-GCP guidelines, FDA regulations, IRB requirements, and sponsor protocols, while contributing to audit readiness and overall site quality. Key ...
Drafting and formatting FDA submissions (e.g., PMTA/MRTPAs, amendments, supplements, and postmarket reports) as well as responses to FDA Information Requests and Deficiency Letters * Creating ...
Drafting and formatting FDA submissions (e.g., PMTA/MRTPAs, amendments, supplements, and postmarket reports) as well as responses to FDA Information Requests and Deficiency Letters * Creating ...
Be Seen First
Regulatory Attorney
New York, NY · Remote
$250K - $350K/yr
FDA REGULATORY ATTORNEY Firm X is seeking an experienced FDA Regulatory Attorney to join its growing FDA and Life Sciences practice. Due to significant client demand and a steady influx of new FDA ...
Quick apply
Be Seen First
Regulatory Attorney
New York, NY · Remote
$250K - $350K/yr
FDA REGULATORY ATTORNEY Firm X is seeking an experienced FDA Regulatory Attorney to join its growing FDA and Life Sciences practice. Due to significant client demand and a steady influx of new FDA ...
Regulatory Assistant
Hialeah, FL · On-site
$20 - $25/hr
This role assists in maintaining adherence to ICH-GCP guidelines, FDA regulations, IRB requirements, and sponsor protocols, while contributing to audit readiness and overall site quality. Key ...
Quick apply
Regulatory Assistant
Hialeah, FL · On-site
$20 - $25/hr
This role assists in maintaining adherence to ICH-GCP guidelines, FDA regulations, IRB requirements, and sponsor protocols, while contributing to audit readiness and overall site quality. Key ...
Maintain deep expertise in key regulatory environments, including EU, FDA, APAC, and LATAM markets, and ensure team members do as well * Monitor and interpret evolving regulations, ensuring the ...
New
Maintain deep expertise in key regulatory environments, including EU, FDA, APAC, and LATAM markets, and ensure team members do as well * Monitor and interpret evolving regulations, ensuring the ...
New
Regulatory Manager
Lehi, UT · On-site
Maintain deep expertise in key regulatory environments, including EU, FDA, APAC, and LATAM markets, and ensure team members do as well * Monitor and interpret evolving regulations, ensuring the ...
Regulatory Manager
Lehi, UT · On-site
Maintain deep expertise in key regulatory environments, including EU, FDA, APAC, and LATAM markets, and ensure team members do as well * Monitor and interpret evolving regulations, ensuring the ...
Regulatory Manager
Lehi, UT · On-site
Maintain deep expertise in key regulatory environments, including EU, FDA, APAC, and LATAM markets, and ensure team members do as well * Monitor and interpret evolving regulations, ensuring the ...
New
Quick apply
Regulatory Manager
Lehi, UT · On-site
Maintain deep expertise in key regulatory environments, including EU, FDA, APAC, and LATAM markets, and ensure team members do as well * Monitor and interpret evolving regulations, ensuring the ...
New
Senior Specialist, Regulatory Affairs and Compliance
Allen, TX · On-site
$124K/yr
Interact with the FDA and other regulatory authorities on all MDR or reportable events. Maintain and prepare device registrations, listings, certifications, export certificates, and Declarations of ...
Senior Specialist, Regulatory Affairs and Compliance
Allen, TX · On-site
$124K/yr
Interact with the FDA and other regulatory authorities on all MDR or reportable events. Maintain and prepare device registrations, listings, certifications, export certificates, and Declarations of ...
Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international ...
Quick apply
Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international ...
The ideal candidate will have strong experience with FDA regulations, regulatory submissions, and lifecycle management activities in regulated environments. Key Responsibilities * Prepare, review ...
Quick apply
The ideal candidate will have strong experience with FDA regulations, regulatory submissions, and lifecycle management activities in regulated environments. Key Responsibilities * Prepare, review ...
Senior Regulatory Affairs Specialist
Pleasanton, CA · On-site
$110K - $150K/yr
Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international ...
Senior Regulatory Affairs Specialist
Pleasanton, CA · On-site
$110K - $150K/yr
Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international ...
Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international ...
Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international ...
Senior Specialist, Regulatory Affairs and Compliance
Allen, TX · On-site
$124K/yr
Interact with the FDA and other regulatory authorities on all MDR or reportable events. Maintain and prepare device registrations, listings, certifications, export certificates, and Declarations of ...
Senior Specialist, Regulatory Affairs and Compliance
Allen, TX · On-site
$124K/yr
Interact with the FDA and other regulatory authorities on all MDR or reportable events. Maintain and prepare device registrations, listings, certifications, export certificates, and Declarations of ...
Senior CAPA FDA Lead
Bothell, WA · On-site
Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness. * Conduct gap assessments against FDA expectations and ...
Quick apply
Senior CAPA FDA Lead
Bothell, WA · On-site
Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness. * Conduct gap assessments against FDA expectations and ...
Fda Regulatory information
See salary details
$18.99 - $22.95
3% of jobs
$22.95 - $26.90
6% of jobs
$26.90 - $30.86
13% of jobs
$31.38 is the 25th percentile. Wages below this are outliers.
$30.86 - $34.81
20% of jobs
The median wage is $36.35 / hr.
$34.81 - $38.77
19% of jobs
$38.77 - $42.72
9% of jobs
$44.70 is the 75th percentile. Wages above this are outliers.
$42.72 - $46.68
10% of jobs
$46.68 - $50.63
6% of jobs
$50.63 - $54.59
5% of jobs
$54.59 - $58.54
5% of jobs
$58.54 - $62.50
3% of jobs
$18
$39
$62
How much do fda regulatory jobs pay per hour?
What are the key skills and qualifications needed to thrive in the Fda Regulatory position, and why are they important?
To thrive in an FDA Regulatory role, you must have a thorough understanding of FDA regulations, submission requirements, and scientific or technical documentation, usually supported by a degree in life sciences or a related field. Proficiency with regulatory submission software (such as eCTD), knowledge of guidance documents, and sometimes RAC certification are highly valued. Strong organizational abilities, problem-solving skills, and clear communication are essential soft skills for coordinating between internal teams and external agencies. These qualifications are vital to ensure compliance, successful product approvals, and effective interaction with regulatory authorities.
What is an FDA Regulatory job?
An FDA Regulatory job involves ensuring that products such as pharmaceuticals, medical devices, and biologics comply with U.S. Food and Drug Administration (FDA) regulations. Professionals in this field prepare and submit regulatory documents, monitor compliance with changing laws, and help companies navigate the approval process. They work closely with internal teams and regulatory agencies to ensure safety, efficacy, and legal adherence.
What are the main responsibilities of someone working in an FDA Regulatory position?
Professionals in FDA Regulatory roles are primarily responsible for preparing, reviewing, and submitting documents to the FDA to support the approval of pharmaceuticals, medical devices, or other regulated products. You will monitor regulatory changes, ensure company practices comply with relevant laws, and serve as a liaison between your organization and the FDA. Daily tasks often involve cross-functional collaboration with research, quality assurance, and product development teams. This role is both fast-paced and detail-oriented, requiring you to manage multiple projects and adapt to evolving regulatory landscapes.

Other
Posted 28 days ago
Job description
Be part of a mission-driven team focused on improving the lives of patients worldwide. In this Regulatory Specialist role, you’ll play a critical part in bringing transformative orthopedic technologies to market, helping surgeons deliver better outcomes, faster recovery times, and higher quality of life for those with musculoskeletal conditions.
Why You Should Apply
- Join a company that thrives on innovation and real-world patient impact
- Collaborate with cross-functional experts in a fast-paced, clinical product environment
- Play a hands-on role in FDA submissions for breakthrough Class II and III medical devices
- Enjoy a culture that blends urgency, teamwork, and a passion for clinical results
What You’ll Be Doing
- Drafting and submitting 510(k), IDE, and PMA regulatory submissions
- Partnering with Product Development teams to align on regulatory strategy
- Reviewing clinical data and collaborating with internal teams to support submissions
- Maintaining PMA records, preparing supplements and annual reports
- Training team members and contributing to SOP development and regulatory compliance
About You
- Be able to do the job as described
- Bachelor’s in health/science-related field; Engineering degree is a plus
- 5+ years’ experience in Regulatory Affairs in the medical device industry
- Knowledge of orthopedic medical devices is highly preferred
- Comfortable with FDA regulatory pathways and submission types (Pre-Sub, 510(k), IDE, PMA)
- Strong documentation, review, and cross-functional communication skills
How To Apply
We’d love to see your resume, but we don’t need it to have a conversation. Send an email to ccupo@jacobsmgt.com and tell me why you’re interested. Or, if you do have a resume ready, apply here.
About Jacobs Management Group
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
11 - 50 Employees
Headquarters location
Philadelphia, PA, US
Year founded
1988