Business Analyst – Regulatory Affairs / RIM

The posting, as FormativGroup wrote it

Is this you?

Are you a Regulatory Affairs Business Analyst who can translate complex regulatory and business needs into clear requirements, process flows, and system-ready documentation? This role is ideal for someone with deep Regulatory Affairs experience who enjoys partnering across business and technology teams to help drive a successful Regulatory Information Management (RIM) implementation.

About the role

The Business Analyst - Regulatory Affairs / RIM will support the business side of a Regulatory Information Management system implementation, serving as a bridge between Regulatory Affairs stakeholders and the teams responsible for delivering the solution.

In this role, you’ll gather and document business requirements, develop current- and future-state process flows, facilitate stakeholder discussions, and translate regulatory processes into clear, actionable requirements for the RIM implementation.

This is not a regulatory submissions production role . Rather than compiling or submitting documents directly to the FDA or other Health Authorities, you’ll use your Regulatory Affairs expertise to help business and technology teams understand regulatory workflows, requirements, and documentation needs so the RIM solution effectively supports the business.

What You'll Work On
As Business Analyst – Regulatory Affairs / RIM, you will:

• Lead or support the business in gathering, organizing, and documenting requirements for a RIM system deployment.
• Create, update, and maintain process flows that reflect Regulatory Affairs business processes and system needs.
• Collaborate with Regulatory Affairs stakeholders, business users, technology teams, and implementation partners to clarify requirements and priorities.
• Support stakeholder discussions, workshops, and working sessions to understand current-state and future-state processes.
• Translate regulatory business needs into clear business requirements, process documentation, and system-supporting materials.
• Apply Regulatory Affairs subject matter expertise to help teams understand Health Authority regulations, regulatory workflows, and RIM-related needs.
• Support documentation related to regulatory submissions processes, annual reports, Health Authority conversations, and related regulatory activities as they connect to the RIM system.
• Help compile and organize documents needed to support a RIM system implementation, including business requirements and related process materials.
• Use tools such as Word, Excel, PowerPoint, and Visio to document requirements, process flows, stakeholder inputs, and project materials.
• Partner with cross-functional teams to ensure business requirements are understood, traceable, and aligned to implementation goals.

What You'll Bring
You will likely be successful in this role if you have:

• 10+ years of Regulatory Affairs experience, with direct experience working in regulatory affairs required.
• Regulatory Information Management experien

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experienced leaders, and help shape how we deliver for clients.

Employment Eligibility

This role is Hybrid, must reside near to Richmond, VA - Not open to travel - must go onsite 1st week and intermittently

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa now or in the future

We are committed to pay equity and transparency. The compensation range for this position represents our good faith estimate of the range we reasonably expect to pay for this role at the time of posting. The actual compensation offered will be determined based on factors such as the candidate’s experience, skills, education, work location, and internal equity.

In addition to hourly pay, employees may be eligible for discretionary bonuses, commissions, or other incentive programs, as well as a comprehensive benefits package that includes medical, dental, vision, 401(k), paid time off, etc.

Estimated hourly Compensation Range

$85 — $95 USD

FormativGroup operates within the critical middle layer of business technology, where applications and systems connect infrastructure to business processes. We are specialists who help the middle market take full advantage of their technology investments with deep, industry-centric expertise, all in one place, to unify fragmented systems. With deep technical expertise across cloud architecture, system integration, AI, and data strategy, we bridge the gap between business goals and modern platforms.

FormativGroup is an equal opportunity employer providing opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

ADA Specifications: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

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