Regulatory Affairs Specialist

Regulatory Affairs Specialist

BLOOMINGDALE, IL 60108

Apply Overview Salary Range $50,000.00 - $60,000.00 Salary Level Entry Position Type Full Time Education Level 4 Year Degree Apply Description Del Medical | Advancing Global Healthcare Innovation At Del Medical, we design and deliver advanced medical imaging solutions that help healthcare providers improve patient outcomes worldwide. As a global leader in diagnostic imaging technology, we are committed to precision, compliance, and innovation at every stage of product development. We are seeking a Regulatory Affairs Specialist who thrives in a fast-paced, highly regulated environment and is passionate about ensuring products meet the highest global standards. This role is critical in enabling Del Medical to bring safe, effective, and compliant medical imaging technologies to market. What You'll Do As a Regulatory Affairs Specialist, you will serve as a key driver of global regulatory compliance and product approvals. You will work cross-functionally with Engineering, Quality, Manufacturing, and Leadership teams to ensure our products meet all applicable regulatory requirements throughout the product lifecycle. Key Responsibilities Prepare, review, and submit regulatory documentation for product registrations, clearances, and approvals (domestic and international). Manage regulatory interactions with agencies to ensure timely approvals and ongoing compliance. Monitor and interpret evolving global regulatory requirements and translate them into actionable guidance. Maintain complete, accurate, and audit-ready regulatory technical files and product documentation. Ensure compliance with labeling, packaging, and product marking requirements for medical imaging systems. Partner with Quality Assurance and Quality Control teams to align regulatory and quality system requirements. Support internal and external regulatory audits, including inspection readiness activities. Provide regulatory guidance to R D and manufacturing teams during product development and lifecycle changes. Support regulatory strategy for product updates, renewals, and lifecycle management. Collaborate across functions to ensure compliance is embedded at every stage of product development. What You Bring Education & Experience Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or related field (Master's preferred). Proven experience in Regulatory Affairs within the medical device or healthcare industry. Strong knowledge of FDA, EU MDR, and other global regulatory frameworks. Core Knowledge Medical device regulatory submission and approval pathways. Quality Management Systems (ISO 13485 or equivalent). Product lifecycle regulatory requirements from concept through post-market surveillance. Skills & Competencies Strong regulatory submission and documentation preparation skills. Excellent attention to detail with a commitment to accuracy and compliance. Strong written and verbal communication skills, including technical writing. Ability to manage multiple regulatory projects and deadlines simultaneously. Collaborative mindset with the ability to influence cross-functional teams. Analytical problem-solving skills with a focus on compliant, practical solutions. Professional Abilities Regulatory intelligence and ability to interpret evolving requirements. High ethical standards and integrity in regulatory decision-making. Strong organizational and documentation management capabilities. Ability to thrive in audit-driven, highly regulated environments. Why Del Medical At Del Medical, you will be part of a mission-driven organization shaping the future of medical imaging.

We offer:

Competitive compensation aligned with experience Comprehensive health, dental, and vision insurance 401(k) retirement savings plan Paid Time Off LTD, STD, Life and AD&D Insurance Career development and growth opportunities A collaborative, innovative, and purpose-driven work environment