Regulatory Affairs Specialist

OBJECTIVE OF THE POSITION:

The position will have broad and critical responsibilities that include supporting regulatory compliance to the Company's (all sites) Quality Management System (QMS) to comply with all governing regulatory bodies such as CLIA, New York State CLEP, College of American Pathologists (CAP), ISO 13485 and FDA QMSR, IVDR and others as they relate to the Company's products and services. This position will be responsible for maintaining company regulatory licensing, certification and permits for all sites.  Preparing and supporting document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company. This position compiles all materials required in submissions, license renewal and annual registrations. The ability to conduct regulatory assessments and gap analyses. Coordinating Regulatory improvement projects. Maintaining Regulatory Intelligence Library with current knowledge base of existing and emerging regulations, standards, and guidance documents.

RESPONSIBILITIES:

·       Accountable for the organization, research, communication, maintenance, and growth of the internal egulatory Intelligence Library and addressing all regulatory inquiries in a timely manner.

·       Maintains list of all applicable Standards and Regulations which apply to all company facilities and products.

·       Maintains internal regulatory licensing, certification and permits for all facilities including renewals, new assay notifications, site or lab director changes, etc. including updating and maintaining current regulatory status on websites (CAP.org, NYS HCS) and internal tracking spreadsheets (submissions, licenses/permits, etc.)

·       Manages and maintains industry standards and guidance subscriptions (CLSI, RAPS, etc.), maintains relationships with industry organizations and communicate any output to stakeholders.

·       Assists with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.

·       Reviews, approves, or escalates copy review and marketing material for compliance with Claims Matrix and applicable regulations.

·       Reviews proposed product changes for impact on regulatory status of the product.

·       Interprets and applies FDA and other industry regulations and standards to business practices and fit for purpose.

·       Assists with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process.

·       Reviews and approves proposed labeling and regulated records and documents for compliance with applicable US and international regulations.

·       Write, edit, and upkeep of departmental standard operating procedures with management and team.

·       Follows internal regulatory affairs policy and procedures.

·       Assist with internal and external audits.

·       May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.

·       Other responsibilities as assigned.

COMPETENCY OR POSITION REQUIREMENTS:

·       Excellent analytical and problem-solving skills.

·       Impeccable communication, presentation and interpersonal skills.

·       Strong data mining and metric presenting skills.

·       Able to travel out-of-state.

·       Must be detail-oriented and possess strong organizational and time management skills with the ability to prioritize and manage completion of multiple tasks/projects, communicating when necessary with company personnel to execute.

·       A motivated self-starter able to perform the required responsibilities with minimal direction.

·       Ability to work as part of internal and remote teams with a strong understanding and appreciation of other department/personnel’s work disciplines.

·       Strong research and regulatory interpretation skills.

·       Ability to apply requirements fit for purpose of the regulatory environment.

·       Competency in Microsoft Office (SharePoint, Teams, Word, Excel, PowerPoint)

EDUCATION AND EXPERIENCE:

·       A Bachelor's/Master’s degree in a scientific discipline or related field and at least 5 years Quality or Regulatory experience in a regulated healthcare environment. Regulatory experience preferred.

·       At least 3 years specific experience in one or more of the following areas:

·       Clinical laboratory experience preferred, as it relates to commercializing a regulated product with an ability to understand the complexities involved with in vitro diagnostic multivariate index assays.

·       Experience with FDA IVD applications and approvals.

·       Experience in a regulated environment and strong knowledge of FDA QMSR, ISO 13485, CLIA/CAP and NYS CLEP regulations and standards.

·       Strong proficiencies with computer skills, Microsoft Office, Microsoft Excel, Microsoft Outlook, PowerPoint, etc.