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
Lead Cerenovus design assurance activities for
all projects to ensure successful transfer of the design to manufacturing.
Support Design History File completion and documentation
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
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)