VP Data Quality Management - San Jose, CA, United States - Tgi Life Sciences

Description

An exciting opportunity to join an early Medical Device start up company based in California.

focusing in the sector of Urology the ideal candidate for the role must have experience in this field and with BPH.

Reports to the President/CEO and serves as a key and active member of the Senior Management/Executive team, interacting with the team to ensure business objectives are aligned and that the company is performing
Responsible for the overall medical device clinical regulatory program development
and implementation, as well as the Clinical management of the company. Develops and executes regulatory
Ensures company policies,
clinical, and regulatory requirements and clearly communicates cross functionally within the organization.

Provides management and leadership to the Clinical and Regulatory organizations in the
development and implementation of clinical and regulatory strategies and processes to gain fastest
or significant business risk.
Provides counsel, training and interpretation of FDA, Health Canada, EMA, and other international
regulatory requirements to all company personnel.
Directs and manages all regulatory submissions and communications to regulatory authorities.
external expertise for submission preparation and filing of all regulatory documents.
Maintains external positive relationships with key opinion leaders, medical directors and regulatory
Identifies issues that may increase regulatory and corporate risks and proposes informed strategies
to address such risks.
familiarity with the regulatory environment and latest regulatory issues, and provides expertise in
translating regulatory requirements into practical, workable plans.
Develops and successfully executes clinical and regulatory strategies and implementation plans to
Directs team development and growth to meet companys clinical and regulatory requirements
Present to board of directors, when needed, all updates and short- and long-range planning for
clinical and regulatory functions.

Provide support to CEO during company fundraising by providing documents and data to be
regulatory status.

BS degree in scientific discipline, MS preferred

The EVP of Clinical, and Regulatory oversees all Clinical, and Regulatory roles within the
Minimum 10 years of leadership experience in clinical and/or regulatory and quality in medical
device and/or pharmaceutical industries.
Clinical Trial Design and Management and Regulatory affairs certification or equivalent