Regulatory Affairs Specialists play a critical role in ensuring that organizations navigate complex compliance frameworks, maintain regulatory alignment, and build defensible quality systems. This is an opportunity to register your interest in future Regulatory Affairs Specialist roles focused on managing regulatory strategy, audit readiness, and risk mitigation across product lifecycles. Please note the content of this advert does not represent a live vacancy. About the opportunity Roles of this type may sit within organizations that need strong regulatory leadership to manage submissions, support compliance initiatives, and coordinate quality system improvements. The work could involve partnering across engineering, quality and operations to ensure regulatory requirements are met, building audit-ready documentation, and helping shape how the organization manages risk and compliance frameworks—particularly in regulated industries where regulatory knowledge and foresight drive business outcomes. Typical role overview

Location:

Chicago, Illinois, United States Type:

Permanent

Full-time Salary:

$110,000 - $190,000 per annum, dependent on experience

Domain:

Regulatory Affairs

• Compliance
• Risk Management
• Quality Systems What you would do Typical responsibilities could include: Managing regulatory submissions, correspondence and compliance documentation Supporting audit preparation and execution, including internal and external audits Coordinating quality system updates and regulatory change management Assessing regulatory risk across product portfolios and lifecycle stages Maintaining relationships with regulatory agencies and managing submission timelines Driving continuous improvement in compliance processes and documentation standards Contributing to regulatory strategy and helping shape organizational compliance posture What you could bring Most roles of this type require the following: Must-have 5-10 years of regulatory affairs, compliance or quality assurance experience Working knowledge of applicable regulatory frameworks (FDA, ISO 13485, GxP or equivalent) Demonstrated audit management and risk assessment experience Strong documentation and technical writing skills Bachelor's degree in Engineering, Business, Finance/Accounting or related field Certified Compliance Professional (CCP) certification or equivalent regulatory credential Authorization to work in the United States Nice-to-have Experience with regulatory submissions in your industry Familiarity with quality management system (QMS) platforms Track record of leading cross-functional compliance initiatives Advanced degree or additional compliance certifications What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: Opportunity to build and strengthen compliance frameworks that protect organizational reputation and patient safety Scope to influence regulatory strategy and shape how the organization manages complex compliance requirements Exposure to cross-functional teams and stakeholder management across engineering, quality and leadership Potential for professional development in evolving regulatory landscapes and emerging compliance trends Competitive compensation, comprehensive benefits including medical, dental and vision coverage, paid time off, 401(k) matching, and flexible work arrangements where applicable About Specialist Staffing Group Specialist Staffing Group partners with organizations across regulated industries to find talented regulatory, quality and compliance professionals.

We understand the complexity of regulatory environments and the expertise required to navigate them effectively. Our mission is to connect experienced professionals with roles where their regulatory knowledge and compliance leadership can drive real impact. How to register interest If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career. Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.