Walker Cole is currently supporting a well established medical device company in hiring for a Clinical Operations Specialist. With a wide portfolio of products, it’s an exciting time to join an established, successful company as they continue to expand:
Responsibilities of Clinical Operations Specialist:
*Oversee clinical study execution, including PMCF, HFE studies, from protocol design to final reporting.
*Ensure all clinical activities comply with global standards.
*Collaborate with cross-functional teams, such as design, marketing, and manufacturing, to provide strategic clinical input throughout the product lifecycle.
*Anticipate challenges in clinical use and compliance, proposing proactive solutions.
*Develop SOPs and train teams on current and emerging regulatory requirements.
*Provide guidance on clinical data and product claims to meet international regulatory standards.
*Coordinate with vendors and internal departments to maintain project timelines, budgets, and scope.
Requirements of Clinical Operations Specialist:
*Must have experience in Medical Device setting.
*Strong project management skills, including planning, execution, and coordination.
*Deep understanding of technical and scientific regulatory requirements.
*Familiarity with key regulatory frameworks, including FDA, Medical Device Regulations, and ISO standards (13485, 14155, 14971).
*Excellent communication and collaboration skills to influence diverse stakeholder groups.
Clinical Operations | Clinical Research | Medical Device | FDA | ISO | Regulatory Frameworks | Clinical Affairs | Product Lifecycle | Vendor coordination