Johnson & Johnson Careers
Senior Regulatory Affairs Specialist
Requisition ID: 1805706166W
· Liaison with R & D to support device development and approval planning and execution.
· Provide guidance to the relevant Cerenovus functions on FDA requirements for both in vivo and in vitro test programmes designed to support submissions.
· Lead Cerenovus design assurance activities for all projects to ensure successful transfer of the design to manufacturing.
· Support Design History File completion and documentation review.
· Generation of IDE, 510k and other submissions as required for Cerenovus products to be marketed in the US.
· Review of labelling and marketing materials in compliance with FDA regulations.
· Preparation of product registration files for submission to global regulatory bodies/agencies, to support EU CE Marking, FDA, and foreign regulatory submissions, in order to obtain product approvals and maintain regulatory compliance with international regulatory requirements.
· Responsible for representing Regulatory on project teams.
· Participation in project work such as new product introductions, changes to existing products and processes, and other company projects as required.
· Generate design documentation risk analyses and essential requirements checklists etc. working with cross functional teams and across sites to support technical files completion.
· Monitor international standards and regulations and maintain standard/regulation implementation plan for site.
· Preparation of quality and regulatory documentation to support the shipment of products.
· Review and evaluate technical and scientific data and reports and incorporate them into documents for submission to the EU, FDA and foreign regulatory agencies
· Pursue relevant information pertaining to new developments in regulatory affairs
· Masters’ Degree in engineering
· 5 years minimum Quality system or regulatory experience in the medical industry a prerequisite.
· Project management skills and leadership ability
· Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2003, Council Directive 93/42/EEC June, 1993 (Medical Device Directive), and the Canadian Medical Device Regulations, 2006 at an advanced level.
· Experience in the preparation and submission of Registration Files, Design Dossiers and Technical Files
· Excellent interpersonal skills and ability to work remotely with people from different cultural backgrounds to achieve results. Pleasant to work with. Driven to make the team succeed.
· Excellent written and communication skills
· Good judgment and problem solving ability with strong understanding of the business and customer impact of decisions.
Neuravi Ltd. (8191)