Ashley Brinks

Q: What is Ashley Brinks email address?

Email Ashley Brinks at abrinks@jenavalve.com. This email is the most updated Ashley Brinks's email found in 2026.

Q: How to contact Ashley Brinks?

To contact Ashley Brinks send an email to abrinks@jenavalve.com. (updated on August 25, 2024)

Senior Regulatory Affairs Specialist at JenaValve Technology, Inc. | Laguna Hills, California, United States

About Ashley Brinks

Ashley Brinks is a dynamic Regulatory Affairs Specialist at JenaValve Technology, Inc., where she plays a pivotal role in navigating the complex regulatory landscape of the medical device industry. With a proven track record of facilitating compliance and expediting product approvals, Ashley is instrumental in supporting regulatory submissions for critical projects, including Expanded Access applications and Annual Reporting for Investigational Device Exemptions (IDE) with the FDA. Her expertise extends to managing substantial change notifications in the European Union and overseeing Serious Adverse Event reporting for clinical trials, ensuring that all regulatory requirements are met with precision and timeliness.

At JenaValve, Ashley has been deeply involved in the regulatory processes for Class III implantable medical devices, including the modular premarket approval application (PMA) and the Technical Documentation for Legacy Devices under the EU Medical Device Regulation (EU-MDR). Her ability to conduct thorough data analysis and maintain quality assurance standards has been essential in driving product innovation while ensuring regulatory adherence. Ashley's collaborative approach enables her to work effectively across cross-functional teams, aligning regulatory strategies with product development goals.

With a strong foundation in quality management and a keen analytical mindset, Ashley is dedicated to advancing the mission of JenaValve Technology. She is always open to new opportunities where she can leverage her regulatory expertise to contribute to the success of innovative medical solutions, ultimately enhancing patient outcomes and safety in the healthcare landscape. Her commitment to excellence and proactive problem-solving makes her a valuable asset in the ever-evolving field of medical device regulation.

Ashley Brinks Work