Regulatory Compliance Engineer

职位描述

To enhance our Team of Global Compliance, we are looking for:

Regulatory Compliance Engineer

Your Responsibilities include and are not limited to:

• supporting internal audits and supplier audits,
• supporting the readiness program for ISO Registration audits, FDA Inspections and customer audits
• Acting as supporting compliance contact for site departments, business units, and corporate functions
• Understand, implement and maintain Compliance programs.
• Support the site’s quality system development, effective maintenance and continued compliance with business unit requirements, medical device regulations and standards (i.e., U.S. – FDA, ISO 13485, Anvisa)
• Supporting the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.
• Performing all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements

What will you bring:

• Educational background in one (or more) of the following fields: Quality, Regulatory, Engineering, Business or Life Sciences
• 3 + years of industry experience within Quality and/or Regulatory
• Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)
• Good computer skills; Word, Excel, PowerPoint
• Good interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally