Title: Senior Director - Regulatory Affairs
Location: San Francisco Bay area
Type: Permanent Role
Notes: No Corp to Corp
The Senior Director, FDA Regulatory Affairs develops, communicates, executes Regulatory strategic initiatives. Responsible for supporting FDA quality system regulations such as 21CFR 801, 803, 806, 820, 21 CFR 1270 and 1271, ISO 13485, IVDR, CAMDCAS as well as any relevant international guidelines.
· Provides direction and oversight on external regulatory projects
Strategic development and intelligence for in vitro diagnostic (IVD) and external diagnostic business and partnering activities.
· Develop and lead strategic regulatory initiatives to support growth of the company's diverse businesses such as Women's Health, Oncology and transplant.
· Drives effective collaborations with General Managers, Business Development, Medical Affairs, Clinical Affairs and Scientific Communications to ensure patient needs and clinical trial objectives are a shared focus leading to scientifically robust and compliant strategies and diagnostic product approvals.
· Is accountable for the performance and results of the FDA related Regulatory organization, including registrations, submissions, supporting clinicals, talent & organizational development, and departmental objectives.
· Develops strategies and plans to meet performance objectives of the organization.
· Manage timelines, budgets and resource allocation according to requirements of the business.
· Demonstrates ability to maintain excellent positive relationships with regulators and auditors as needed.
· Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
· Must maintain a current status on company's training requirements.
· Employee must pass post offer criminal background check
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