Job Description:
We are seeking a Medical Device Safety Specialist to support clinical trial operations and medical safety reporting for medical devices and combination products. This role involves query resolution, addenda writing, data quality assurance, and collaboration with regional contract CRAs. The specialist will manage clinical study files, provide medical support, and contribute to adverse event investigation and reporting. Additionally, they will engage in cross-functional collaboration with Medical Affairs, Clinical, and Regulatory teams to prepare documentation for health authorities.

Key Responsibilities:

• Investigate and document adverse events, device complaints, and SADE potential cases.
• Perform individual and periodic medical device safety reporting, including serious adverse events (SAE) processing.
• Provide support for principal investigator (PI) site notifications and safety consultations.
• Collaborate on continuous improvement projects across departments.
• Deliver internal training on safety issues and contribute to automation initiatives.
• Ensure compliance with risk management regulations and industry standards for medical devices and combination products.

Required Qualifications & Skills:

• Experience: Clinical trial and medical device experience in a Contract Research Organization (CRO) or related industry.
• Technical Skills: Proficiency in Office, data analysis, research, and data automation. Experience with electronic databases such as Rave EDC, Veeva EDC, Oracle, and Salesforce.
• Education: Bachelor of Science in Nursing (BSN) or related field; RN licensure required.
• Regulatory Knowledge: Understanding of ICH-GCP, CFR, EU-MDR, and medical device safety reporting requirements.

Core Competencies:

• Strong problem-solving and decision-making abilities.
• Effective cross-functional collaboration and stakeholder influence.
• Ability to manage multiple tasks with attention to detail and high-quality output.
• Strategic thinking, negotiation, and process improvement expertise.
• Results-driven with a focus on meeting challenging milestones.

Pay Range: $40/hr. - $47/hr.