Regulatory Affairs Specialist

DEL MEDICAL INC•Bloomingdale, IL

1d•Onsite

About The Position

Del Medical is 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. 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.

Requirements

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.
Medical device regulatory submission and approval pathways.
Quality Management Systems (ISO 13485 or equivalent).
Product lifecycle regulatory requirements from concept through post-market surveillance.
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.
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.

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.