Regulatory Clinical Affairs Specialist 3
Are you looking to be a part of something exceptional? If working for Siemens Healthineers in the Point of Care (POC) Business Area peaks your interest, then this opportunity is for you! We are looking for a person experienced in Clinical Affairs (i.e. Clinical Operations) to join our enthusiastic and collaborative team.
The selected individual will:
- Initiate, design and coordinate in vitro diagnostic studies to collect data to support submissions to regulatory authorities and future product development
- Take responsibility of ensuring the execution of clinical trials with the goal of adhering to target timelines, budget and quality
- Report to Director, Pre-Market Clinical & Regulatory Affairs, Quality Technology, Point of Care Business Area
- Manage clinical trials, which may include protocol, ICF and CRF development, investigational product / supply management, budget / contract negotiation and regulatory document collection / management
- Monitor clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, utilizing knowledge of the diagnostic area sufficient to perform source data verification and monitor study protocol conduct / compliance; occasional handling of biological samples may be required, based upon project need
- Assist clinical sites with IRB submission / documentation, as needed
- Utilize a working knowledge of GCP and SOPs to assure compliance with FDA regulations and applicable processes and procedures
- Anticipate and identify problems / issues and implement resolutions or provide recommendations for corrective actions in relevant job areas
- Work cross-functionally with Regulatory Affairs and Quality Management, as workload permits, to support efforts in these areas
Required Knowledge/Skills, Education, and Experience
- BS/BA in life science discipline or equivalent combination of education and experience
- Demonstration of 5-8 years of successful experience in related field and successful performance of responsibilities presented above
- CCRA certification with ACRP or SoCRA
- Experience in in vitro diagnostics and/or the medical device industry
- Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical trial reports, etc.)
- Demonstration of effective oral communication skills with clinical sites, and internal / external personnel from various departments / levels
- Ability and willingness to travel, domestic and international, depending upon project need, periodically up to 30-50% domestically; <10% internationally
Preferred Knowledge/Skills, Education, and Experience
- Medical Technologist or equivalent (hospital) laboratory background
- Experience with Pre-Subs and 510k submissions
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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