Regulatory Affairs Specialist

About iCAD:

iCAD, a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered solutions that enable medical providers to accurately and reliably detect cancer earlier and improve patient outcomes. Headquartered in Nashua, N.H., iCAD’s industry-leading ProFound Breast Health Suite provides AI-powered mammography analysis for breast cancer detection, density assessment and risk evaluation. The ProFound Breast Health Suite is cleared by the U.S. Food & Drug Administration (FDA) and has received CE mark and Health Canada licensing. Used by thousands of providers serving millions of patients, ProFound is available in over 50 countries.

The Role:

In collaboration with the CTO and VP/Director of QA/RA, this role will be pivotal in assisting with driving the strategic direction of global regulatory affairs functions. The focus of this role includes regulatory submissions, interactions with regulatory agencies (including FDA and Notified Body), while meeting deadlines and filing dates for the regulatory compliance and filings.

This position reports directly to the VP/Director of Regulatory Affairs and Quality Assurance and ensures that RA activities are planned; that resources are allocated; priorities are established, and activities are executed to meet business goals.

Responsibilities:

• Assist in securing world-wide regulatory approvals for the company’s products in conformity with the European Medical Devices Directive - 93/42/EEC, FDA’s PMA, PMA supplement, and 510(k) submissions regulations, and international (e.g., Health Canada) licensing requirements. Obtain product approvals, certifications, and licenses where necessary for US and worldwide market release.
• Assist in the international regulation process for company products by ensuring that all necessary submissions/applications are filed and by managing all necessary interactions with government agencies.

• Support planning and execution of clinical trials in support of Class II and Class III regulatory filings in accordance with Good Clinical Practices (GCP)

• Support development of policies and standard operating procedures to ensure regulatory compliance of company operations.
• Assist in the release of the company’s finished products for commercial distribution; ensure that all released products meet their specifications.
• Assist in the review and approval of product labeling and promotional materials to ensure that they conform to regulatory requirements.
• Promote awareness of regulatory and customer requirements throughout the organization.

Competencies:

• Requires a bachelor's degree with at least 2+ years of progressive regulatory affairs leadership experience in the medical device and health tech industry.

• International regulatory experience is a must!

• Experience with FDA Class II, software controlled medical devices is required; Class III medical device experience is highly preferred.
• Experience with AI related detection and diagnostics software filing is required.
• MS in technical field preferred.
• Exposure to establishing and maintaining corporate procedures as they relate to the FDA Quality System Regulations, ISO 13485, the Medical Device Directive 93/42/EEC and the EU Medical Device Regulations.
• Experience in assisting with coordinating and creating documentation for regulatory submissions, including: 510(k), PMA, PMA Supplements and PMA annual reports (United States; FDA), technical file (European Community; CE Mark) or international license applications.
• Knowledge of Good Clinical Practices (GCP).
• Knowledge and experience in working in a developmental engineering environment, creating, and documenting prototype devices and providing support through design and manufacturing phases regarding FDA regulatory, documentation, testing and inspection requirements.
• Exposure to implementation of design controls with emphasis on the creation of Hazard/Risk Analysis, Failure Mode and Effects Analysis (FMEA), and design history file / design review documentation.
• The ability to interpret regulatory standards and communicate findings to the team.
• A positive attitude and a team player with exceptionally good interpersonal skills and the ability to communicate with highly specialized research and development scientists, engineers and marketing people is a must.
• Excellent verbal and written communication skills.

iCAD is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, layoff or termination. ICAD does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation. If you have a disability and need assistance applying for this position or accommodations with an interview, please email icadhumanresources@icadmed.com