Regulatory Specialist
About The Position
OXOS Medical, Inc. empowers every provider with the capability, clarity, and confidence to make accurate decisions at the point of care. We are building new kinds of radiographic imaging devices that push the boundaries of previous solutions by improving image quality, reducing radiation exposure, improving ease of use, and building solutions to deliver care outside of traditional scenarios. We enable anyone anywhere to access radiologic diagnostics at the point of need, expanding availability and changing how healthcare is delivered. OXOS is searching for a Regulatory Specialist to join our high-growth company. You will join a dynamic team of passionate people who work daily to change how radiographic diagnostics are delivered. The Regulatory Specialist will execute regulatory processes and manage requirements for innovative radiographic medical devices at OXOS with the aim of changing the way healthcare is delivered. They will ensure compliance with FDA and international regulations while supporting the company's growth objectives through effective regulatory strategy and implementation.
Requirements
- Bachelor’s Degree or higher in biomedical engineering, life sciences, regulatory affairs or related field
- Regulatory experience in an FDA-regulated medical device industry
- Working knowledge of MDSAP, ISO 13485, ISO 14971, and IEC 60601 standards
- Attention to detail
- Strong analytical and technical skills
- Clear, effective, and precise written and verbal communication
- Excellent organizational skills
- Project management skills
- Problem solving skills
Responsibilities
- Manage regulatory requirements
- Prepare and submit regulatory documents
- Ensure regulatory compliance
- Keep various teams informed on the regulatory landscape
- Stay up-to-date on key regulatory changes
- Oversee regulatory compliance and support the development of strategy for novel medical devices, including FDA regulations, state regulations, and international standards
- Keep abreast of the national and global regulatory landscape
- Ensure a cohesive business strategy informed by the Regulatory Affairs team
- Manage the pipeline of regulatory submissions for all OXOS products
- Collaborate with all teams to ensure that submissions are accurate, compliant, and timely
- Strategic planning with the Regulatory Affairs team
- Project planning with the Project Management Office
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
