Specialist, Regulatory Affairs - New York


: $165,260.00 - $165,260.00 /year *

Employment Type

: Full-Time


: Information Technology

Title: Specialist, Regulatory Affairs
Location: SoHo, New York City, United States

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 expected.

About the Role:
We are looking for a Specialist to help create our Regulatory Affairs team for Click s medical device mobile applications. The Specialist will have a key role in developing regulatory strategy for our novel digital therapeutics, and in drafting, submitting and supporting Click s global regulatory filings, interactions/meetings, and overall compliance. The Specialist is expected to be closely familiar and stay current with evolving FDA and international medical device regulations, including the medical device sections of 21 CFR, FDA Guidance documents, Software as Medical Device (SaMD) policy and the EU MDR. This person will work alongside Click s Quality Management, Clinical Operations and Program Management teams, and interface with Click s development partners to help bring Click s medical device software to market. The Specialist will report to the Chief Strategy Officer and is a newly created position with significant growth potential.

This is a highly visible, creative, and agile role within a rapidly growing pre-IPO company in a nascent and fast-growing space. The role will be located in our trendy SoHo HQ, includes great benefits, and is an excellent wealth-building/equity opportunity for the right individual.

Develop and execute innovative regulatory strategies across a variety of healthcare treatment indications
Perform regulatory intelligence research to inform regulatory scenario planning and path-to-market
Draft, submit and support Click s global regulatory filings, interactions/meetings, and overall compliance
Work closely with Click s product teams and commercialization partners to effectively manage regulatory requirements
Manage and support the establishment Click s Regulatory Affairs policies and processes throughout the organization
Directly support QMS processes including but not limited to preparing and maintaining technical files
Keep updated on and inform colleagues of new FDA requirements, publications, global regulations, and industry trends so that Click remains on the leading edge of digital medicine

3-5+ years of experience working in Regulatory Affairs with FDA-regulated class II medical devices
Detailed understanding of FDA and global regulatory requirements for medical devices
Ability to oversee and progress multiple simultaneous projects as part of a cross-functional team
Strong verbal and written communication skills to clearly convey complex medical, scientific and technological concepts
Bachelor s degree with a concentration in STEM
Plus: Experience working with Software as Medical Device (SaMD) or regulated medical device software
Plus: History of successful FDA submissions, meetings and market authorizations
Plus: Experience in creating and maintaining medical device technical files
Plus: Working knowledge of the European Medical Device Directive/Medical Device Regulation
Plus: Experience with FDA 21 CFR 820 and ISO 13485 medical device quality management systems
Plus: Working knowledge of ISO 14971 and IEC 62304 standards
Plus: Experience in developing and writing SOP s or other technical writing
Plus: Experience working in environments governed by data privacy law such as HIPAA or GDPR

Stock options | Competitive salary with annual review | 401(k) with company 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 benefits | Monthly catered lunches | Choice of Apple or PC equipment | Sponsored company events | Free, unlimited office snacks and beverages | Much more

For immediate consideration, please send your CV as an attachment to: ...@clicktherapeutics.com

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.

by Jobble

Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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