Principal Clinical Affairs

Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates.

About Us

Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. We’re developing the first and only multi-modal point-of-care platform that enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system.

Our platform spans many markets including the clinical, veterinary, and food safety industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure.

At the core of our company’s identity is a strong foundation in engineering. We take great pride in our commitment to critical thinking and pragmatic problem-solving through a modular and systemic perspective.

We hold the conviction that transparent communication, coupled with the flexibility to adjust to evolving scenarios and the willingness to venture beyond familiar territories, is crucial to both our success and yours.

About the Role

This is an opportunity to be a part of a small but passionate team with a big impact! You will be involved in all things Regulatory at Fluxergy, responsible for ensuring our processes, procedures, and product meet ISO13485 and FDA requirements.

You will play an important part in the company's long-term strategy. We are looking for someone that is eager to learn and ready to collaborate.

Sound interesting? We’d love to hear from you!

Team Culture

• Passionate
• Proactive
• Detail Oriented
• Solution Driven
• Growth

What You'll Do

• Conducts on-site and remote monitoring activities for external clinical studies, including site enrollments, site management, interim and closeout visits.
• Manages deliverables from Regulatory, R&D, Logistics, and external CROs to ensure effective coordination.
• Monitors the regulatory status of clinical studies and mitigates GCP risks.
• Manages IRB activities, including submissions, amendments, continuing review reports, and document expiration notifications.
• Ensures compliance of clinical studies with regulatory requirements, GCP guidance, and company policies.
• Establishes biocollection protocols, manages biocollection program, and maintains associated program records to support R&D.
• Safeguards clinical samples, data, and records, ensuring confidentiality, integrity, security, and PHI protection.
• Maintains regulatory, legal, and financial disclosure documents.
• Supports regulatory inspection activities as needed.

What You'll Need to Have

• At least 5 years of managing clinical studies.
• Experience collaborating with Regulatory, R&D, Operations personnel, and CROs. Managing investigational devices, study supplies, and biocollection programs.
• Knowledge of Good Clinical Practice (GCP) guidelines and IRB activities (submissions, amendments, reviews).
• Ability to organize and verify the accuracy and completeness of clinical study records and source data / documents.
• History of demonstrating study integrity by safeguarding clinical samples, data, and records.

Interview Process

Our interview processes may differ slightly from role-to-role; however, most of our interviews will follow a similar pattern :

• Recruiter Interview
• Hiring Manager interview
• On-site Interview
• Decision

We are an early-stage company and may change our interview process from time-to-time, but our hope is everyone who interviews with us has a positive experience, even if an offer isn’t presented.

Fluxergy Benefits

• Medical / Dental :
• 99% medical benefit premiums (gold and platinum level) are paid by Fluxergy and covers you, your partner, and / or dependents.
• 100% dental and vision (PPO) premiums paid for the Fluxergy employee, partner, and / or dependents.
• 100% Life Insurance premiums paid for employee.
• Work / Life Balance Minded PTO :
• 15 paid vacation days.
• 2-week paid winter break.
• 7 company paid holidays.
• 5 paid sick days.
• Promote from within : many of our current leaders started their career with Fluxergy!
• Wear lots of hats / accelerate your career growth!
• We are a flat organization by design lots of visibility!

Salary : $150,000 - $165,000

Additional Information

Fluxergy is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, marital status, age, disability, national or ethnic origin, military service status, citizenship, or other protected characteristic.

Fluxergy participates in the E-Verify program. Please click here, here, here for more information.

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