Acro Service Corp · 1 day ago
Regulatory Affairs Specialist
Lake Forest, IL
Full-time
Hybrid
Entry, Mid Level
$30/hr - $35/hr
2+ years expAcro Service Corp is seeking a Regulatory Affairs Specialist to provide regulatory support and expertise for U.S. and global medical device submissions. This role will support execution of global regulatory strategies, ensure compliance with FDA, EU, and international requirements, and collaborate cross-functionally to enable timely product approvals.
ConsultingInformation TechnologyStaffing Agency
Hiring Manager
Vivek Kumar
Responsibilities
Provide regulatory support for U.S. and global submissions, including analysis of requirements and tracking deliverables
Assist with execution of global regulatory strategies and maintenance of global registration dossiers
Ensure regulatory compliance for submissions, change management, and product approvals (FDA, CE, and international certifications)
Plan, prepare, and organize registration packages aligned with regional regulations and guidelines
Support responses to regulatory agencies and notified bodies with oversight
Partner with regional and country Regulatory Affairs teams to assess regulatory impact of product changes
Review and approve technical and regulatory documentation; identify deficiencies and drive resolution
Track assigned regulatory activities and manage multiple deadlines with high accuracy
Represent Global Regulatory Affairs in R&D meetings and present regulatory positions
Support special projects as assigned
Qualification
Required
Strong understanding of FDA, EU, and global regulatory submission requirements
Hands-on experience preparing regulatory submissions and securing approvals
Experience assembling global dossiers and authoring CE technical documentation
Solid knowledge of 21 CFR 820 and ISO 13485:2016
Experience working directly with regulatory agencies and notified bodies
Strong analytical skills with ability to critically assess scientific arguments
Excellent written and verbal communication skills
Strong problem-solving, organizational, and interpersonal skills
Ability to balance regulatory compliance with business needs
Bachelor's degree required (pharmacy, biology, chemistry, pharmacology, engineering, or related field preferred)
2–4 years of Regulatory Affairs experience in the medical device industry
Direct FDA and global submission experience required
Proven project management, multitasking, and prioritization skills
Ability to work independently with minimal supervision
Preferred
RAC certification preferred
Company
Acro Service Corp
With singular global reach and agility, Acro Service Corporation offers you a unique integrated approach to staffing and consulting solutions.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Chris Ehrhart, CCWP
VP - Global Supplier Partnerships
Staci Dodson Beurer SPHR, SHRM-SCP, CSP
Chief People Officer (VP, HR)
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