Description
A San Francisco Bay Area based company is seeking a Senior Regulatory Manager for their growing team. The Senior Regulatory Manager will manage the regulatory work of all products to comply with, and are approved by global regulatory bodies. This will involve domestic and international submissions for medical devices and biologic products.Responsibilities:
- Primary liaison for Regulatory affairs on project teams, providing support to ensure compliance with regulatory provisions
- Manage regulatory projects, including domestic and international submissions
- Develop and implement regulatory strategies for new and existing products on a timely basis
- Prepare and manage submissions and correspondence to FDA as well as international bodies for regulations
- Work with cross-functional teams in developing global strategies for products and marketing.
- Responsible for leading a team that delivers timely compilation and of all necessary documentation for regulatory submissions to support technical content of regulatory submissions.
Requirements:
- BS or BA (life sciences strongly preferred)
- 4+ years experience in Regulatory Affairs in the medical device, pharmaceuticals or biotech industry.
- Knowledge of QSR, and GMP requirements.
- Strong problem solving skills and ability to deal with changing priorities.
- Excellent project management skills.
To find out more about Real please visit www.realstaffing.com