Vice President Regulatory Affairs/Quality Assurance
|Job Title:||Vice President Regulatory Affairs/Quality Assurance|
|Location:||San Diego, California|
|Contact Name:||Pavlina Bullaj|
|Job Published:||January 04, 2017 16:29|
SciPro Global are a professional Life Science recruitment consultancy specialising in Regulatory Affairs, Clinical Affairs, Research & Development with offices in London, Munch, New York and San Francisco.
As a specialist Regulatory Affairs consultant, I am currently looking for a Vice President Regulatory Affairs/Quality Assurance with a minimum of 15 years industry experience.
As the VPRA/QA you will be responsible for the leadership, oversight and management of the regulatory and quality functions in compliance with government regulations for drugs and medical devices.
You will be in charge of managing all aspects of regulatory and quality strategy development and implementation and communicating directly with global regulatory agencies (US FDA, EU, ISO, and others) on all regulatory matters. This includes overseeing product submissions for regulatory agency clearance and approval, providing input into clinical studies used to support product submissions, overseeing the quality management system and contributing to regulatory agency inspections. In addition to providing leadership to regulatory and quality, the Vice President of RA & QA will provide input to product development and collaborate closely with the Leadership Team to define the strategic direction of the organization and to drive business growth.
- Supervises all employees in Regulatory Affairs and Quality Assurance
- Responsible for hiring within the departments
- Responsible for employee performance management of departments
Education and Qualifications:
- An advanced or professional degree in life sciences, chemistry or biology
- Experienced professional with 15+ years of experience in regulatory affairs and/or quality assurance, preferably in women's health or related discipline
- Expert knowledge of global registration requirements, ICH regulations, safety requirements, and promotional regulations for drug products and devices including experience with IND, NDA, OTC, IDE, PMA, 510(k) submissions
- Demonstrated leadership, strategic planning, and technical skills
- Experience with FDA drug and device regulations and guidelines
- Previous experiences working with CDER and CDRH
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