Regulatory Affairs Specialist

About Del Medical

Del Medical is a global leader dedicated to enhancing healthcare through advanced medical imaging solutions. We strive to improve patient outcomes worldwide by ensuring precision, compliance, and continuous innovation throughout our product development process.

Role Overview

We are seeking a Regulatory Affairs Specialist who excels in dynamic, highly regulated industries and is committed to ensuring our medical imaging products meet the strictest global standards. This role is essential for facilitating the safe and compliant introduction of our technologies to market.

Key Responsibilities

• Develop, evaluate, and submit regulatory documents to secure product registrations, clearances, and approvals both domestically and internationally.
• Manage communications and compliance activities with regulatory agencies to guarantee timely approvals.
• Keep abreast of changes in global regulatory landscapes and translate these into practical internal requirements.
• Maintain comprehensive, precise, and audit-ready regulatory technical files and product documentation.
• Ensure that all labeling, packaging, and marking requirements for medical imaging equipment comply with applicable regulations.
• Coordinate with Quality Assurance and Control teams to integrate regulatory and quality system requirements.
• Support preparation and execution of regulatory audits and inspections.
• Provide regulatory advice to research and development, and manufacturing teams during stages of product design and lifecycle modifications.
• Assist in shaping regulatory strategies for product modifications, renewals, and ongoing lifecycle management.
• Foster cross-functional collaboration to embed regulatory compliance throughout the development process.

Required Qualifications

• Bachelor’s or Master’s degree in disciplines relevant to Regulatory Affairs or Life Sciences.
• Demonstrated experience in regulatory professions within the healthcare or medical device sectors.
• Extensive understanding of both local and international regulatory frameworks.
• Exceptional organizational skills and meticulous attention to detail.
• Strong communication capabilities and team collaboration skills.
• Familiarity with quality management system standards and procedures.

Preferred Qualifications

• Background in clinical research or healthcare delivery.
• Experience preparing and updating clinical evaluation plans (CEP) and clinical evaluation reports (CER) compliant with EU Medical Device Regulation standards.
• Ability to manage document development and approval workflows, coordinating review processes and revisions across teams within stipulated timeframes.
• Skilled in performing systematic literature reviews, data evaluation, and synthesis for safety and performance assessments.

Why Join Del Medical

• Opportunity for training to cultivate specific role skills.
• Competitive salary package corresponding with experience.
• Comprehensive medical, dental, and vision insurance plans.
• 401(k) retirement savings program.
• Paid time off benefits.
• Insurance coverage including Long Term Disability, Short Term Disability, Life, and Accidental Death & Dismemberment.
• Pathways for professional growth and career progression.
• An encouraging, collaborative, innovative, and mission-oriented workplace culture.

Work Environment

This position requires working on site in Bloomingdale, Illinois.