Director, Regulatory Affairs

DIRECTOR, REGULATORY AFFAIRS

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 AI 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 SVP Quality and Regulatory Affairs , this role will be pivotal in driving global regulatory affairs. The focus of this role includes international regulatory submissions, interactions with regulatory bodies (including Notified Body, Authorized Representatives and Local Health Authorities ). This role partners with the business to support them in meeting the company needs of global expansion.

This position reports SVP Quality and Regulatory Affairs and ensures that RA activities are planned; that resources are allocated; priorities are established, and activities are executed to meet business goals.

Responsibilities:

• Secure world-wide regulatory approvals for the company's products in conformity with the Medical Devices Regulation (EU) -2017/745, and local regulations Obtain product approvals, certifications, and licenses where necessary for target country market release.

• Oversee 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.

• Maintain international licenses and registrations

• Provide education on the impact of regulatory changes that affect iCADs products

• Support development of policies and standard operating procedures to ensure regulatory compliance of company operations.

• Oversee 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 10+ years of progressive regulatory affairs leadership experience in the medical device and health tech industry.

• International regulatory experience with software as a medical device, AI is preferred.

• Experience with FDA Class II, software;

• Experience with AI related detection and diagnostics software.

• MS in technical field preferred.

• Experience coordinating and creating documentation for regulatory submissions, including: 510(k),), technical documentation (European Community; CE Mark) or international license applications.

• Must have a working knowledge of Good Clinical Practices (GCP).

• Experience 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.

• Experience with design controls with emphasis on the creation of Hazard/Risk Analysis, Failure Mode and Effects Analysis (FMEA), and design history file / design review documentation.

• Must have the ability to interpret regulatory standards.

• 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