Senior Staff Specialist, Regulatory Affairs

Job Title: Senior Staff Specialist, Regulatory Affairs - Individual Contributor
Location: Cary, IL (Onsite)
Pay range: $55 - $60/hr
Duration: 12+ Months (possibility of extension & conversion depending on the performance)

Job description:

Core Responsibilities

• Develop and execute global/regional regulatory strategies across product lifecycle
• Provide regulatory guidance for product design, development, manufacturing, and marketing
• Assess regulatory requirements, classifications, and approval pathways (US, EU MDR, global markets)
• Prepare, review, and submit regulatory filings (e.g., US 510(k), EU Class IIa Technical Documentation)
• Monitor and manage regulatory authority interactions, reviews, and communications
• Anticipate regulatory risks and propose mitigation strategies
• Support market access requirements (reimbursement, distribution, regional regulations)
• Ensure compliance with quality, clinical, and preclinical regulatory requirements
• Evaluate product changes for regulatory impact and submission needs
• Maintain post-market surveillance, reporting, and vigilance activities
• Develop and improve SOPs and ensure organization-wide compliance
• Train and advise cross-functional teams on regulatory requirements
• Support inspections, audits, and regulatory authority interactions

Experience & Education

• BS in Engineering/Science or MS in Regulatory Science
• ~6+ years of medical device regulatory experience
• RAC certification preferred

Key Expertise

• Strong knowledge of US FDA regulations (510(k)) and EU MDR (Class IIa)
• Experience with regulatory submissions, approvals, and technical documentation
• Understanding of risk-benefit analysis, clinical/nonclinical data requirements
• Ability to manage cross-functional teams and regulatory negotiations
• Strong communication, strategy, and problem-solving skills

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.