Avera Health·Sioux Falls, South Dakota
The Regulatory Specialist prepares and submits clinical research documents to sponsors, IRBs, and the FDA while ensuring compliance with regulatory standards. They also collaborate with community partners and investigators to support study start-up and maintain accurate regulatory documentation.
You Belong at Avera Be part of a multidisciplinary team built with compassion and the goal of Moving Health Forward for you and our patients. Work where you matter.
Works under general direction to perform professional-level clinical research regulatory assignments. Prepares and completes regulatory documents for protocols as requested by investigators, sub-investigators, and clinical research coordinators. Submits all required research documents to the protocol sponsor, the Institutional Review Boards (IRB), the FDA, and any other regulatory agency as required by the research project. This position works with researchers and partners in community-based settings and is responsive to the unique needs of community settings, such as tribal communities, schools, and non-profits, while aligning with standard regulatory expectations.
What you will do
The individual must be able to work the hours specified. To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds. These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer.
Required Education, License/Certification, or Work Experience: Bachelor's 2 years regulatory, quality or data analyst
Preferred Education, License/Certification, or Work Experience: 1-3 years related research experience and/or training
Expectations and Standards
You Need & Then Some Avera is proud to offer a wide range of benefits to qualifying part-time and full-time employees. We support you with opportunities to help live balanced, healthy lives. Benefits are designed to meet needs of today and into the future. PTO available day 1 for eligible hires. Up to 5% employer matching contribution for retirement Career development guided by hands-on training and mentorship Avera is an Equal Opportunity Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, Veteran Status, or other categories protected by law. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1-605-504-4444 or send an email to talent@avera.org.
Candidates must hold a bachelor's degree and possess at least 2 years of experience in regulatory, quality, or data analysis roles. Strong communication skills and the ability to work effectively in a multidisciplinary team environment are essential.
Market context
In South Dakota, Regulatory Specialist openings are typically driven by organizations that need help keeping policies, documentation, and reporting aligned with changing standards. These roles are competitive because employers often look for a bachelor’s degree plus at least 2 years in regulatory, quality, or data analysis work, along with strong communication and teamwork skills. Review the AI-summarized requirements and benefits here to save research time, then tailor your application to show examples of compliance work and multidisciplinary collaboration.