37 Fda jobs in Silver Spring

Enjoy what you do while contributing to a company that makes a difference in people's lives. US Fertility, is one of the premier fertility centers in the United States, continually seeks experienced, compassionate, and dynamic team players who are committed to delivering exceptional patient care to join our growing practice.

The work we do building families offers stimulation, challenge, and personal reward. If you're looking for a new opportunity to work in a fast-paced, professional environment where your talent contributes to changing people's lives, then we want to talk to you.

We are seeking a detail-driven and proactive Regulatory Coordinator to join our Clinical Operations team. This mid-entry level position plays a vital role in maintaining compliance with FDA regulations related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), including oversight of screening, testing, and documentation for egg and sperm donors. The Regulatory Coordinator ensures adherence to federal and state requirements, supports inspections, and partners closely with clinical and operational teams to uphold regulatory integrity.

We have an immediate opening for a full-time Regulatory Coordinator working Hybrid M-F 8am-5pm.

How You'll Contribute:

We always do whatever it takes, even if it isn't specifically our "job." In general, the Senior Analyst is responsible for:

• Regulatory Oversight & Compliance
• Ensure FDA-required donor screening and testing are completed within required timeframes.
• Review and track laboratory results and documentation to confirm FDA eligibility determinations.
• Monitor and maintain compliance with 21 CFR Part 1271 and state tissue bank regulations.
• Support FDA and state inspections, including preparation of documents, sta4 coordination, and response plans.
• Documentation & Audit
• Conduct quality assurance (QA) and quality control (QC) audits of donor records, physical exam forms, and test results.
• Identify gaps or inconsistencies in documentation and escalate appropriately.
• Ensure accurate recordkeeping in alignment with FDA regulations and internal policies.
• Training & Process Improvement
• Collaborate with clinical operations leaders to identify compliance-related training needs.
• Assist in developing and delivering targeted training based on sta4 performance and regulatory requirements.
• Participate in performance improvement initiatives and internal audits.
• SOPs and Policy Management
• Draft, revise, and maintain standard operating procedures (SOPs), policies, and job aids related to donor eligibility, lab testing, and compliance.
• Ensure all updates reflect current regulatory guidance and best practices.
• Cross-Functional Collaboration
• Work closely with clinical teams, laboratory sta4, and third-party vendors to ensure timely coordination of testing, documentation, and eligibility reviews.
• Support other departments during audits or regulatory reviews.

What You'll Bring:

• Bachelors degree in a health sciences, biology, public health, or related field (or equivalent experience).
• Minimum 1-2 years of experience in regulatory, compliance, clinical operations, or laboratory coordination.
• Prior experience in reproductive medicine, IVF, or tissue banking is strongly preferred.
• Working knowledge of FDA HCT/P regulations, particularly 21 CFR Part 1271.
• Familiarity with donor eligibility determination processes.
• Exceptional attention to detail with a commitment to accuracy and documentation integrity.
• Strong critical thinking and problem-solving skills.
• Ability to understand both granular detail and broader organizational impact.
• Professional communication skills, including clear written documentation and e4ective crossfunctional collaboration
• Ability to manage time e4ectively and work independently within defined regulatory timelines.
• Proven ability to write and maintain SOPs and procedural documents.
• Comfort working in a fast-paced environment with shifting regulatory priorities.

More important than the best skills, however, is the right person. Employees who embrace our mission, vision, and core values are highly successful.

What We Offer:

• Competitive pay + bonus
• Comprehensive training
• Medical, dental, vision, and 401(k) matching
• Generous paid time off and holidays
• Retirement plan
• Tuition assistance
• Ability to make an impact in the communities we serve

At US Fertility, we promote and develop individual strengths in order to help staff grow personally and professionally. Our core values - Empathy, Patient Focus, Integrity, Commitment, and Compassion (EPICC) guide us daily to work hard and enjoy what we do. Were committed to growing our practice and are always looking to promote from within. This is an ideal time to join our team!

To learn more about our company and culture, visit here.

How To Get Started:

To have your resume reviewed by someone on our Talent Acquisition team, click on the Apply button. Or if you happen to know of someone who might be interested in this position, please feel free to share the job description by clicking on an option under Share This Job at the top of the screen.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Enjoy what you do while contributing to a company that makes a difference in people's lives. US Fertility, is one of the premier fertility centers in the United States, continually seeks experienced, compassionate, and dynamic team players who are committed to delivering exceptional patient care to join our growing practice.

The work we do building families offers stimulation, challenge, and personal reward. If you're looking for a new opportunity to work in a fast-paced, professional environment where your talent contributes to changing people's lives, then we want to talk to you.

We are seeking a detail-driven and proactive Regulatory Coordinator to join our Clinical Operations team. This mid-entry level position plays a vital role in maintaining compliance with FDA regulations related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), including oversight of screening, testing, and documentation for egg and sperm donors. The Regulatory Coordinator ensures adherence to federal and state requirements, supports inspections, and partners closely with clinical and operational teams to uphold regulatory integrity.

We have an immediate opening for a full-time Regulatory Coordinator working Hybrid M-F 8am-5pm.

How You'll Contribute:

We always do whatever it takes, even if it isn't specifically our "job." In general, the position is responsible for:

• Regulatory Oversight & Compliance
• Ensure FDA-required donor screening and testing are completed within required timeframes.
• Review and track laboratory results and documentation to confirm FDA eligibility determinations.
• Monitor and maintain compliance with 21 CFR Part 1271 and state tissue bank regulations.
• Support FDA and state inspections, including preparation of documents, sta4 coordination, and response plans.
• Documentation & Audit
• Conduct quality assurance (QA) and quality control (QC) audits of donor records, physical exam forms, and test results.
• Identify gaps or inconsistencies in documentation and escalate appropriately.
• Ensure accurate recordkeeping in alignment with FDA regulations and internal policies.
• Training & Process Improvement
• Collaborate with clinical operations leaders to identify compliance-related training needs.
• Assist in developing and delivering targeted training based on sta4 performance and regulatory requirements.
• Participate in performance improvement initiatives and internal audits.
• SOPs and Policy Management
• Draft, revise, and maintain standard operating procedures (SOPs), policies, and job aids related to donor eligibility, lab testing, and compliance.
• Ensure all updates reflect current regulatory guidance and best practices.
• Cross-Functional Collaboration
• Work closely with clinical teams, laboratory sta4, and third-party vendors to ensure timely coordination of testing, documentation, and eligibility reviews.
• Support other departments during audits or regulatory reviews.

• Bachelor's degree in a health sciences, biology, public health, or related field (or equivalent experience).
• Minimum 1-2 years of experience in regulatory, compliance, clinical operations, or laboratory coordination.
• Prior experience in reproductive medicine, IVF, or tissue banking is strongly preferred.
• Working knowledge of FDA HCT/P regulations, particularly 21 CFR Part 1271.
• Familiarity with donor eligibility determination processes.
• Exceptional attention to detail with a commitment to accuracy and documentation integrity.
• Strong critical thinking and problem-solving skills.
• Ability to understand both granular detail and broader organizational impact.
• Professional communication skills, including clear written documentation and e4ective crossfunctional collaboration
• Ability to manage time e4ectively and work independently within defined regulatory timelines.
• Proven ability to write and maintain SOPs and procedural documents.
• Comfort working in a fast-paced environment with shifting regulatory priorities.

• Competitive pay + bonus
• Comprehensive training
• Medical, dental, vision, and 401(k) matching
• Generous paid time off and holidays
• Retirement plan
• Tuition assistance
• Ability to make an impact in the communities we serve

The Global Government Affairs (GGA) team aims to create broad alignment between Visas business objectives and public policies that affect the payments industry. Externally, the GGA team engages a wide range of stakeholders to raise awareness of and Regulatory Affairs, Operations Analyst, Regulatory, Analyst, Support, Communications, Business Services

• Prepare, review, and submit regulatory documents (e.g., INDs, NDAs, ANDAs, BLAs, variations, annual reports) to health authorities, primarily the FDA.
• Interpret and apply complex regulatory guidelines and provide strategic advice to internal teams (R&D, Clinical, Manufacturing, Marketing).
• Manage and maintain regulatory databases and tracking systems to ensure accurate and up-to-date information.
• Serve as a primary liaison with regulatory agencies, facilitating clear and timely communication.
• Assess the regulatory impact of product changes and guide the necessary actions.
• Participate in multidisciplinary project teams, providing regulatory input and strategy.
• Stay current with evolving regulatory requirements and industry best practices.

• Bachelor's degree in a life science (e.g., Pharmacy, Chemistry, Biology, Biotechnology) or a related field. Master's degree or RAC (Regulatory Affairs Certification) preferred.
• Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry.
• In-depth knowledge of FDA regulations (21 CFR), ICH guidelines, and other relevant international regulatory frameworks.
• Proven experience in preparing and submitting regulatory dossiers.
• Exceptional attention to detail, organizational skills, and ability to manage multiple priorities.
• Strong written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly.
• Proficiency in document management systems and e-submission software.

• Prepare, review, and submit regulatory documents to health authorities (e.g., FDA, EMA) for new drug applications (NDAs), investigational new drug applications (INDs), and variations.
• Interpret and apply complex regulatory guidelines and provide strategic advice to project teams on regulatory requirements.
• Liaise and negotiate with regulatory agencies regarding product submissions, approvals, and post-market commitments.
• Maintain current knowledge of evolving regulatory landscape, including changes in laws, regulations, and guidelines.
• Collaborate with cross-functional teams including R&D, clinical development, manufacturing, and quality assurance to ensure regulatory compliance throughout the product lifecycle.
• Manage and maintain regulatory databases and documentation systems.
• Assess the regulatory impact of product changes and provide guidance on necessary submissions.
• Participate in regulatory inspections and audits, assisting in the preparation and response.
• Develop and implement regulatory strategies for product development and registration.
• Review promotional materials and labeling for regulatory compliance.
• Contribute to the development of internal SOPs related to regulatory affairs.

• Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Life Sciences) or a related field. Master's degree or RAC (Regulatory Affairs Certification) is a plus.
• 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• In-depth knowledge of FDA regulations (21 CFR), ICH guidelines, and other relevant global regulatory requirements.
• Proven experience in preparing and submitting regulatory dossiers (e.g., eCTD format).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to interpret and apply complex scientific and regulatory information.
• Strong analytical, problem-solving, and organizational skills.
• Ability to work independently and collaboratively in a fast-paced, highly regulated environment.
• Proficiency in regulatory information systems and Microsoft Office Suite.
• Experience with post-market surveillance and pharmacovigilance is a plus.

Job Summary: Our client, a leading global pharmaceutical company focused on innovative drug development, is seeking a highly diligent Regulatory Affairs Specialist to join their team in Washington, D.C., US . This hybrid role is crucial for ensuring that all pharmaceutical products and processes comply with local and international regulatory requirements, particularly those set by the FDA. The Regulatory Affairs Specialist will be responsible for preparing, submitting, and managing regulatory filings, as well as providing strategic guidance on regulatory pathways. This position offers a significant opportunity to contribute to bringing life-changing medications to market while ensuring patient safety and product efficacy.

Key Responsibilities:

• Prepare and submit regulatory filings, including INDs, NDAs, ANDAs, and amendments, to health authorities (e.g., FDA, EMA).
• Interpret and apply regulatory guidelines and requirements to product development, manufacturing, and commercialization activities.
• Liaise and negotiate with regulatory agencies on behalf of the company, addressing inquiries and resolving issues.
• Provide strategic regulatory guidance to R&D, clinical, manufacturing, and marketing teams throughout the product lifecycle.
• Review and approve labeling, promotional materials, and product information for regulatory compliance.
• Monitor changes in regulatory legislation and guidance, assessing their impact on company products and operations.
• Maintain accurate and organized regulatory documentation and databases.
• Participate in internal and external audits, ensuring regulatory readiness.
• Collaborate with international regulatory teams to align global submission strategies.
• Develop and implement regulatory strategies for new product registrations and post-market changes.

Qualifications:

• Education: Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related scientific field. Advanced degree (MS, PharmD) or RAC certification preferred.
• Experience: 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with strong experience in US FDA regulations.
• Skills: In-depth knowledge of pharmaceutical regulatory requirements (e.g., 21 CFR, ICH guidelines), excellent written and verbal communication skills, strong analytical and organizational abilities, experience with electronic submission systems.
• Attributes: Detail-oriented, meticulous, strong ethical standards, excellent interpersonal skills, ability to work under strict deadlines, proactive in problem-solving.

Why Join Our Client?
Our client offers a vibrant and inclusive work environment where innovation is encouraged and career growth is prioritized. You will have the opportunity to play a vital role in bringing critical pharmaceutical products to patients worldwide. They are committed to fostering a culture of excellence and providing their employees with the resources and support needed to thrive. This position provides a unique chance to make a substantial impact on public health and contribute to groundbreaking medical advancements. They believe in empowering their team members and fostering a collaborative atmosphere where every voice is heard and valued. If you are passionate about regulatory affairs and eager to take on challenging responsibilities in a leading pharmaceutical company, we encourage you to apply.

Join to apply for the Senior Regulatory Affairs Specialist role at Katalyst CRO Join to apply for the Senior Regulatory Affairs Specialist role at Katalyst CRO Get AI-powered advice on this job and more exclusive features. The Sr. Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex new devices and post market changes within our Ultrasound business. Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams. Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. Responsibilities The Sr. Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex new devices and post market changes within our Ultrasound business. Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams. Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. Requirements You've acquired 5+ years of experience in the medical device regulatory or quality assurance field. Your skills include knowledge of quality system requirements and FDA and/or international product approval process, demonstrate a track record in obtaining FDA clearances and worldwide registrations, clinical trials and software development/regulatory submissions and authoring 510K's. Experience with Software is a must. You have a Bachelor's degree in life sciences or a related field. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Regulatory Affairs Specialist” roles. Washington, DC $146,000.00-$18,000.00 1 week ago Washington, DC 124,200.00- 138,000.00 2 weeks ago Sr. Associate Counsel, Global Regulatory Affairs Washington, DC 176,800.00- 230,000.00 1 week ago Corporate Counsel – Transactions & Regulatory Affairs Sr Regulatory Affairs Strategy Specialist Washington, DC $9 ,700.00- 152,900.00 1 week ago Corporate Counsel – Transactions & Regulatory Affairs Washington, DC $1 3,200.00- 222,200.00 3 weeks ago EHS and Sustainability Regulatory Consultant Corporate Counsel – Transactions & Regulatory Affairs Herndon, VA $1 3,200.00- 222,200.00 3 weeks ago Washington, DC 74,100.00- 147,800.00 3 days ago Associate Director Regulatory Affairs Post Marketing Rockville, MD 140,000.00- 175,000.00 4 months ago Data Privacy Regulatory Compliance Consultant Managing Director, Regulatory & Industry Affairs, Grid Washington, DC 80,000.00- 90,000.00 2 days ago Regulatory Affairs Specialist - Murtha Cancer Center Research Program Bethesda, MD 64,200.00- 109,200.00 3 days ago Regulatory Affairs Examination and Monitoring Lead Associate Washington, DC 121,000.00- 158,000.00 1 day ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr