Who We Are

Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. Major pipeline expansion and progression is in process.

About the Role

The Quality Management Systems Analyst has a key role in implementing and supporting Click’s Quality Management System to help align Click’s product life cycle processes and cross-functional operations with evolving medical device regulations and standards. Candidates must be proactive and creative in leading efforts to produce innovative process solutions to help accommodate Click's pipeline progression, maintain compliance, and ensure Click’s standards of product safety, efficacy, and quality. The Analyst reports to the Manager of Digital Therapeutic (DTx) Quality.

Responsibilities

• Play a leading role in the implementation and oversight of Click’s Quality Management System (QMS) processes throughout the organization.
• Partner with cross-functional teams to find innovative and comprehensive operational solutions that enable the rapid commercialization of safe and effective software as a medical device (SaMD) products.
• Enhance quality system procedures to enable on-going process improvements and the expansion of Click’s quality system to support product commercialization in world-wide markets.
• Manage Click’s electronic document management system, CAPA processing, complaint handling, and training processes.
• Define and monitor performance metrics including quality objectives.
• Conduct quality system audits and liaise in Notified Body, FDA, or other third-party audits.
• Research and monitor SaMD and DTx industry trends and publications, FDA news and announcements, and international standards. Apply learnings to the Quality Management System so that Click remains on the leading edge of digital medicine.

Qualifications

• 1-3 years of experience working in medical device, software, or other regulated industry. A standout candidate has experience with SaMD.
• Knowledge of medical device quality system regulation including FDA 21 CFR 820 and ISO 13485. Experience working with EU MDD/MDR and familiarity with software standards (IEC 62304, AAMI TIR 45) is preferred.
• Highly motivated, driven, and enthusiastic about improving processes and procedures in an innovative, fast-paced environment.
• Strong attention to detail and the ability to write clear procedures and other technical documents.
• A bachelor’s degree with a strong academic track record.
• Experience working in environments governed by data privacy law such as HIPAA or GDPR is preferred.

Benefits

Stock options | Competitive salary with annual review | 401(k) matching | Annual performance-based cash bonus | Comprehensive medical benefits through Aetna | Flexible Spending Accounts | Life insurance and disability benefits | Open vacation policy / unlimited PTO | Generous paid parental leave | Commuter subsidies | Monthly catered lunches | Choice of Mac, Windows, or Linux equipment | Sponsored company events | Free, unlimited office snacks and beverages | Much more…

Equal Employment Opportunity

Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics.