Johnson & Johnson Careers

Senior Regulatory Affairs Specialist

Galway, Ireland
Quality (Eng)


Job Description

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


Qualifications

·         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.



Primary Location
Ireland-Galway-Galway-
Organization
Neuravi Ltd. (8191)
Job Function
Quality (Eng)
Requisition ID
1805706166W