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Role and Responsibilities (including any line reports)
· Responsible for establishing and implementing the global regulatory diagnostics strategy which is aligned with the co-development and commercialization strategies of the gene therapy(ies) concerned in key markets including EU and US.
· Provide strategic direction and operational regulatory support as the Functional Lead on the project teams and other groups within company as required.
· Manages submission activities for a variety of device regulatory approvals including CE marks, Q-submissions (including briefing books), US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
· Provides support to marketed products, e.g., review engineering changes, labelling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to EU, US and international regulatory requirements.
· Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations and maintenance of international regulatory approvals to market devices.
· Review, interpret, and report on product specific regulatory issues including evolving regulatory intelligence that may have material impact on the business units, the corporation, or the customer to the Regulatory leadership and concerned Regulatory Gene Therapy Product Leads.
· Lead and manage interactions with Regulatory Authorities/Stakeholders as appropriate (e.g. CDRH, CLIA, Notified Bodies, etc.).
· Interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
· Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
· Taking responsibility for training of staff in regulatory matters as required · May perform other duties as required or assigned.
Qualification, Education and Experience Requirements
· Bachelor degree in science, engineering, or related technical field; advanced degree preferred.
· Minimum 5 to 7 years experience in regulatory IVD preferably in EU + US where EU is a minimum.
· Experience with Microsoft based applications and general knowledge of PC functions necessary.
· Proven experience in managing budgets and vendors is preferred. · Experience with regulatory submissions including CE-marking, clinical trial notifications, IDE, 510(k), and PMA submissions.
· Awareness of IND, NDA/BLA, CTA and MAA as a minimum.
· Experience in diagnostics or biomarker development with emphasis on gene therapy/oncology a plus
· A demonstrated ability to create and drive an effective regulatory strategy to support commercialization.
· Experience of planning and leading meetings with the key regulatory stakeholders e.g. FDA, Notified Bodies and CLIA.
· A track record of ability to handle critical issue effectively with demonstrated creativity in solving regulatory issues