Regulatory Specialist

About the Role

At Techcyte, the Regulatory Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. They prepare filings and track applications for licensing, certification, and permits and interact with governmental officials during the regulation and certification process. Additionally, they monitor compliance with existing regulations and upcoming or changing regulations, perform impact analysis of regulatory changes and produces status reports, and participate in processes to report, investigate, and address any issues of non-compliance. 

Responsibilities

• Become familiar with Techcyte's software services
• Communicate with product manager, developers and testers to understand product details
• Collaborate with regulatory and technical staff
• Produce regulatory documentation including design history file documents
• Create FDA pre-submissions and submissions
• Create international technical files including for CE marking in Europe
• Perform and document internal audits for regulatory bodies
• Participate in external audits by regulatory bodies and business partners
• Create and maintain the information architecture
• Make high-quality documentation that meets standards, is appropriate and easy to use
• Research and create product submissions for territories outside of the US
• Ensure compliance with document control process and other company processes
• Take meeting minutes in technical design reviews

Qualifications

• A minimum of a Bachelor's degree

• Experience writing FDA and EU submissions

• Post market experience in medical devices

• Experience in regulatory strategy

• Experience in clinical studies, trials and design

• Experience performing internal audits for regulatory compliance and participating in external audits by regulatory bodies

• Background in medical devices, sciences, software or engineering companies

• Knowledge of regulated products (e.g., FDA, CE, ISO, Design Controls)

• Understanding of statistical methods and application from clinical study perspective

About the Company

Improve the World

Our mission is to improve healthcare and laboratory testing throughout the world. We improve the work environment for our users, improve the accuracy of tests, and lower costs and turnaround times for the healthcare system. We push new innovation in technology, workflow, and regulations to make the healthcare system the best it can be. We have already improved accuracy in laboratory testing that has prevented misdiagnoses, and we are striving to do more.

Challenging Hard Problems

We need to analyze the equivalent of a Blu-ray movie worth of images in the cloud in only a few minutes while staying reliable and accurate. Major challenges include transferring, processing, and storing terabytes of data; creating queuing systems that balance turnaround times with costs; and building a pipeline around machine learning models that meet the accuracy requirements of human healthcare.

Work from Home

While we do have offices available for use, our workforce spends the majority of their time working from the comfort of their home. Every team member has a daily standup meeting to touch base with their team and a monthly all hands meeting for the whole company to get updates. Additional meetings are created as needed, and the majority are impromptu.

Benefits

We offer perks to help our employees thrive!

• Competitive salaries

• Medical, dental, and vision insurance

• 401k plan

• 15 paid time off days a year

• Unlimited sick time

• 11 paid holidays

• Target bonus plan

• Equity

• Company provided laptop

• Initial work from home equipment allowance

Techcyte provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Techcyte complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

All candidates must be legally authorized to work in the US, as we are unable to sponsor or transfer Visas at this time. Criminal background checks will be conducted after an employment offer.

Techcyte participates in E-Verify, the government program that certifies an employee's right to work for us in the U.S. For more information go to www.dhs.gov/E-Verify.

Techcyte welcomes all applicants for this position. Should you be individually selected to participate in an assessment or selection process, accommodations are available upon request in relation to the materials or processes to be used.

Please note that for this position, we accept applications on an ongoing basis. There is no set deadline for submitting your application.