Biology, Clinical Assessment, Clinical Medicine, Clinical Research, Clinical Trial, Communication Skills, Cross-Functional, Detail Oriented, Documentation, Embedded Systems, External Audit, Healthcare, Healthcare Providers, Internal Audit, International Health, Interpersonal Skills, Interpret Regulations, Leadership, Maintain Compliance, Manufacturing, Medical Equipment, Medical Imaging, Organizational Skills, Patient Care, Product Development, Product Documentation, Product Lifecycle, QA Partner Testing Software, Quality Control, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Requirements, Regulatory Submissions, Research & Development (R&D), Team Player, Time Management, Writing Skills
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.
Qualifications:
- Bachelor's or Master's degree in a relevant field (Regulatory Affairs, Life Sciences, etc.).
- Proven experience in regulatory affairs within the medical device or healthcare industry.
- In-depth knowledge of local and international regulatory requirements.
- Strong attention to detail and organizational skills.
- Excellent communication and interpersonal skills.
- Familiarity with quality management systems and processes.
Desired Qualifications:
- Clinical Research, or Clinical Care experience
- Author, prepare and/or update clinical evaluation plans (CEP) and reports (CER) for medical devices/systems in accordance with EU MDR requirements.
- Manage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members.
Conduct systematic literature searches, appraisal, analysis, and summarization of data for state-of-the-art, safety and performance periodically.
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