Trace Custer's Email & Phone Number

💼 Past Experience

Trace Custer has experience in Quality Systems design and implementation, Regulatory Affairs, and Operations Excellence. In his role as Global Head of Quality Systems at Invitae, he managed a network of four Oncology testing facilities and developed and implemented a quality control system, achieving ISO-15189 standards of performance. He was also responsible for the development of harmonization strategy to integrate four independent QMS into one and successfully migrated paper-based system to electronic document control. In his previous role at Genzyme, he was responsible for the QC and QA programs for high- complexity clinical testing facilities,document control, and internal audits. He possesses skills in Test Development, Business Development, and Customer Satisfaction.

🎓 Education

Trace Custer's Educational Background:Trace Custer has a regulatory Affairs Certificate from the Medical Devices, Regulatory Affairs professional society. Tracy Custer has a B.A. Biology from the University of Iowa in 1985.In 2014, Trace Custer completed a Medical Devices, Regulatory Affairs Professional Society (RAPS) candidacy training program from the University of Iowa. This program is designed to prepare registered nurses and other health care professionals to an appreciation of the complex regulatory environment in which medical devices are developed and sold.Custer's professional experience includes working as a registered nurse in the Office of the Secretary of State of Iowa between 2014-2018. As a registered nurse in the Office of the Secretary of State of Iowa, Custer had the opportunity to work in a variety of professional fields including regulatory affairs. In her previous work experience, Custer has recognized that the regulatory affairs field is crucial in the safe and successful development and sale of medical devices. As a result, she has actively pursued additional education in this field. In 2019, Custer completed a regulatory affairs online course offered through the University of Iowa's Health Affairs program. This course was designed to provide an appreciation for the bureaucratic process behind the regulatory examination of medical devices.Custer is currently working as a consultant in the Medical Devices industry in the United Kingdom. In this work, Custer is responsible for providing educational and technical support to Doctors in their working with medical device companies. As a consultant in the Medical Devices industry, Custer has more experience in the regulatory atmosphere of the British market than she does in the United States. As a result, she is in a better position to provide commentary on the risks and benefits of developing and selling medical devices in the British market.Custer's future goals include completing a masters degree in medical device technology and post-doctoral work in the field of medical device regulation. She alsopires to become a registered nurse in the United States and work in a regulatory affairs setting.

💡 Technical & Interpersonal Skills

Trace Custer's interpersonal skills:Trace Custer is a highly skilled interpersonal individual who is able tovisory and manage relationships effectively. Trace also has experience in operational and management related disciplines and is able to translate this into effective leadership.Trace is highly communicative and able to convey information quickly and effectively. She also has a strong knowledge of the industry and its requirements, which makes her an valuable resource to any organization. Additionally, Trace is attentive to the needs of others and is always prepared to offer her advice or help when needed.Lastly, Trace is highly self- conscious and vets her interactions thoroughly before beginning a conversation. This ensures that she is able to maintain a healthy and positive relationship with everyone she meets.