Employment Spot

Job Description

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

Successful candidate will assist the Sr. Director of Clinical and Pre Market Regulatory Affairs in managing clinical studies, research collaborations, pre-market regulatory submissions, preclinical studies and publication activities in support of corporate objectives.  Candidate will be responsible for the following:

• Ongoing responsibility for managing the research collaborations program.
• Develop and maintain strong relationships with key physicians, physicists, customers and other health-care professionals as appropriate.
• Attend procedures and obtain product development feedback.
• Provide mentoring to department staff.
• Occasionally monitor clinical study data at sites to ensure regulatory and protocol compliance and to provide mentoring to other department staff.
• Conduct other site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim 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.
• Ensure management of product inventories for clinical studies and research activities.
• Ensure maintenance of research documentation.
• Ensure clinical studies and research activities are conducted in a timely manner and within site budgets.
• Establish and enhance the clinical credibility of the Company within the radiation therapy community.
• Assist with generation of protocols, CRFs, Informed Consent documents, Instructions for Use, Operator's Manuals and site training materials development for pre and post market studies.
• Assist with report preparation.
• Help maintain Departmental SOPs, policies and training to ensure quality of Departmental programs.
• Execute projects in accordance with plan and budget.

Job Requirements

Minimum five (5) years experience in management of significant-risk clinical studies involving complex medical devices; Minimum one GLP preclinical study submitted to FDA

PhD degree in Life Sciences, health sciences, biomedical engineering or equivalent degree/experience