The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Ensure that the regulatory requirements and company organizational goals are effective and in compliance. Provide expertise and guidance regarding domestic and international regulatory and quality requirements needed to meet product development projects, complaints, adverse reactions/events, field actions, regulatory reporting, internal and external auditing, supplier quality, document preparation, performance metrics and review of certain controlled documents. This position also provides guidance to AlloSource customers and AlloSource personnel.
Essential Duties and Responsibilities: • Develop, implement, and maintain procedures in support of regulatory compliance. • Assist with the development and implementation of regulatory strategies for existing, new and modified products. • Provide review and approval of product and process changes, as required, to ensure compliance with regulatory requirements. • Assist in developing and documenting sound regulatory decisions and justifications and advising organization on impact of changing regulations. Interpret product, policy and process changes to ensure compliance with regulatory requirements. • Assist with the creation and maintenance of regulatory documents and claims, and up to date (regulatory changes, business changes, new indications) labeling for products. • Review and approval of labeling and marketing collateral to ensure substantiation of claims, adequate information, and cautions/warnings are present and that all labeling is in conformance to regulatory requirements in accordance with Federal, state, and other applicable regulatory and quality requirements. • Assist with the timely preparation and submission of domestic regulatory submissions (pre and post market), and submission of Technical Files and/or international regulatory submissions, as well as internal regulatory file documentation, ensuring they meet appropriate standards and content requirements. • Oversee Complaint Handling, Adverse Reaction/Event Reporting, Deviation reporting, Recall, and Regulatory License/Registration systems. • Oversee internal audit system (Schedule, create checklist, communication, opening meetings, conduct audits, closing meetings, creating audit report, maintain internal/external audit files and records, and overseeing corrective actions.) • Oversee Supplier Quality program • Host customer audits (plan, document and act as primary contact) and respond to audit findings. • Ensure completion of customer quality/regulatory surveys, maintain survey files. • Develop/provide reports for applicable quality metrics. • Oversee regulatory audits & responses in cooperation with, Regulatory and Quality Leadership. • Provide guidance to staff in Regulatory and inspection matters. 06/22/2021 • Assist as a resource in Regulatory and Quality department planning and budgeting. • Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies. • May perform other related duties and responsibilities as assigned.
5-7 years’ regulatory/quality experience in an FDA regulated industry in the medical product space (ex: tissue banking, medical device, biologics or pharmaceutical) • 3 years’ supervisory experience in an FDA regulated environment in the medical product space • Previous experience preparing and submitting regulatory product submissions (i.e. TRG, 510(k), PMA, IND, BLA) • Direct experience with multiple Quality Systems and Regulatory Affairs processes, e.g. CAPA, Complaints, Post-market reporting, product development, pre-market regulatory submissions • Experience working in or managing cross-functional teams • Previous audit participation and/or oversight of internal audits, regulatory audits, or supplier audits • Proficiency in Microsoft Office applications
Telecommuting is allowed.
Internal Number: 2449
AlloSource restores hope to donor families and helps patients heal through its innovative cellular and tissue allografts. Over the past 25 years, the company has continued to advance its processes and products, so surgeons have the biologics needed to heal their patients.