Job Description

Position: Regulatory Affairs Specialist

Location: Oakwood Village, Ohio

About ViewRay Systems

ViewRay Systems, Inc. is a private technology company seeking to provide the global radiation therapy community with advanced medical instruments incorporating the highest level of technology possible. Our belief is that only significant technological innovation can enable society to conquer disease. Our mission is to dare to change the paradigms of medicine and solve “impossible” technical problems to enable clinicians to effect a cure to save precious human lives, mitigate pain and suffering, and enhance quality of life. Our vision is to become the world’s leader in producing highly effective innovative technology to cure cancer.

ViewRay Systems designs, manufactures, and markets the MRIdian A3i® radiation therapy system to treat cancer patients with the smallest radiation therapy margins available [i] with the highest patient throughput demonstrated for the most complicated cases [ii] The system treats by aligning the sharpest radiation therapy beam on the market to diagnostic quality magnetic resonance images (MRIs) of the patient, adapts the treatment plan to the reality of the patient, and then uses the real-time MRIs to control the beam and record real-time doses delivered to the patient.

Job Description

ViewRay Systems, Inc. is looking for a Regulatory Affairs Specialist that shares our passion for conquering cancer and help us support radiation therapy systems worldwide. The ideal candidate shares enthusiasm for engaging in the best business practices while improving cancer therapy. You will be assisting with worldwide regulatory submissions and compliance activities.

Responsibilities include the following and other duties may be assigned

• Regulatory Submissions: Preparing, reviewing, and submitting regulatory documents (e.g., 510(k), PMA, CE Mark) to relevant authorities (e.g., FDA, EMA).
• Compliance: Ensuring adherence to all applicable regulations, standards, and guidelines (e.g., FDA QSR, ISO 13485).
• Regulatory Intelligence: Monitoring changes in regulations and advising internal teams on their implications.
• Communication: Liaising with regulatory agencies and managing communications and negotiations.
• Documentation: Maintaining accurate regulatory documentation and records.
• Training & Guidance: Providing regulatory guidance and training to cross-functional teams (e.g., R&D, Quality Assurance, Marketing).
• Risk Assessment: Conducting regulatory risk assessments and providing recommendations.
• Strategy Development: Developing and implementing regulatory strategies for medical device products.
• Other tasks as assigned by company management.

Education, Experience, Skills

• Four-year college degree in a technical field.
• 5+ years in FDA-regulated, medical device, software development, and manufacturing environments required.
• Regulatory Affairs Certification (RAC) preferred.
• Demonstrable successes in the core regulatory concepts of leadership, ethics, business acumen, scientific innovation, registration strategy, and post-market surveillance.
• Strong ability to seek information based on initial direction and on project objectives.
• Ability to read, interpret, and apply technical material.
• Excellent proofreading, English grammar, spelling, and punctuation skills.
• Strong communication skills.
• Highly organized, able to handle multiple tasks at same time.

Personal Interactions

• Creative, flexible, and collaborative in approach to technical problem solving.
• Ability to communicate effectively, both orally and in writing, at a variety of technical levels.
• Ability to work effectively as part of the diverse team including physicists, scientists, and engineers in a fast-paced environment and with multiple projects.

Job Type: Full-time

Pay: Depends on experience

Ability to Relocate: Cleveland, OH 44128: Relocate before starting work (Required)

Work Location: In person in Cleveland, OH: Relocate before starting work (Required)

Benefits :

• Health, dental, and vision insurance
• Paid time off and flexible schedule
• Office stocked with snacks, drinks, and occasional catered meals

Email inquiries to careers@viewraysystems.com

ViewRay Systems, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, creed, national origin, gender, age, sexual orientation, status as a protected disabled or Vietnam Era Veteran, disability, or any other legally protected status.

[i] Kishan AU, Ma TM, Lamb JM, et al. Magnetic Resonance Imaging–Guided vs Computed Tomography–Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. JAMA Oncol. 2023;9(3):365–373. doi:10.1001/jamaoncol.2022.6558

[ii] Claudio Votta, et al. , Evaluation of clinical parallel workflow in online adaptive MR-guided Radiotherapy: A detailed assessment of treatment session times, Technical Innovations & Patient Support in Radiation Oncology,

Volume 29, 2024, 100239doi:10.1016/j.tipsro.2024.100239

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