Regulatory Coordinator - FDA Compliance & Donor Screening

Shady Grove Fertility • Remote • 1w ago

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 (flexible).

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.

What You'll Bring:

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.

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. We’re 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.