Senior Regulatory Affairs Specialist


  • Company:
    J&J Family of Companies
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    1 week ago
  • Category:
    General

·
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