Manager of Clinical and Pre Market Regulatory Affairs

ClinForce is currently seeking a Manager of Clinical and Pre Market Regulatory Affairs for Seattle, WA.

Successful candidate will manage clinical and pre-market regulatory affairs projects including, Pre-IDE submissions, protocol development, IDE submissions, clinical site selections and initiation, clinical study progress, data management, monitoring, report preparation and 510(k) submission.  Other responsibilities include the following:

• Prepare clinical study protocols, reports and other study documentation; prepare Pre-IDE, IDE and 510(k) submissions.
• Generate CRFs, Informed Consent documents, Instructions for Use, Operator's Manuals and site training materials development for pre- and post-market studies.
• Interact directly with clinical sites, including clinical investigators and other health care professionals involved in the clinical study and maintain a positive rapport with each site.
• Attend procedures to support sites (e.g., provide guidance in case report form (CRF) completion) and obtain product development feedback.
• Assist with monitoring clinical study data at sites to ensure regulatory and protocol compliance as necessary.
• Conduct other site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim site visits and study close-out visits), as required.
• Generate clear and concise trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.) and, as required, clinical summaries.
• Manage product inventories for clinical studies.
• Maintain study documentation (e.g., correspondence, deviations, budget information).
• Assist with manuscript and abstract preparation for publications.
• Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and IDE) associated with preclinical and clinical studies.
• Act as a liaison between clinical sites.
• Maintain project schedules to ensure project milestones are met.
• Ensure projects are conducted within budgets.
• Travel 50% at times.