Director, Regulatory Affairs & Quality Assurance
- Director, Regulatory Affairs & Quality Assurance
Title: Director, Regulatory Affairs & Quality Assurance
Location: Gaithersburg, MD
The Director, Regulatory Affairs & Quality Assurance is a core member of the DxNow, Inc., team, directly responsible for the development and implementation of the Company's Quality Management System as well as CE, ISO and FDA filings. This is a hands-on position requiring intimate involvement with all aspects of medical device regulatory and quality policy, procedure and implementation.
- Develop and implement a Quality Management System for DxNow's medical devices.
- Prepare and submit regulatory applications such as FDA 510(k), CE and ISO.
- Demonstrate an intimate knowledge of U.S. and international UDI labeling requirements and coordinate the implementation of such requirements.
- Review device labeling and promotional material to ensure compliance with U.S. and international regulations.
- Act as a core member of the Company's development and manufacturing teams, providing regulatory affairs feedback and guidance.
- Perform internal and external audits to assure compliance with Company policy as well as agency requirements and regulations.
- Review product and/or manufacturing changes for compliance with DxNow and external applicable policies and/or regulations.
- Establish, track and manage regulatory project timelines.
- Maintain well-organized, auditable regulatory files.
- Manage quality-related activities with outside vendors.
- Provide quality training to staff.
- Other duties as required.
- 5-10 years' hands-on life sciences regulatory experience. Ideally, experienced in 510(k) medical devices.
- In-depth knowledge of quality management systems.
- Past successful submissions of CE, ISO and FDA 510(k).
- Minimum of Bachelor's degree in life sciences or engineering. Advanced degree preferred.
- Ability to leverage the learnings and wisdom from regulatory/quality experience to help advise and support effective management decision-making.
- Hands-on, action-oriented.
- High-energy, motivated to achieve and succeed.
- Self-starter able to work autonomously and within a cost-constrained environment.
Posting ID: 567174738Posted: 2020-08-09