Senior Compliance Specialist

职位描述

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

Senior Compliance Specialist

to lead assigned Quality System processes.

Your Responsibilities include and are not limited to:

• Leading internal audits and supplier audits,
• Leading the readiness program for ISO Registration audits, FDA Inspections and customer audits
• Preparing submissions and responses to FDA and ISO Registrars
• Acting as the primary compliance contact for site departments, business units, and corporate functions
• Acting as a subject matter expert for the Quality Systems and Compliance programs.
• Ensuring 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
• 6 + 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)
• Experience with compliance assessments, gap assessments and risk assessments.
• Experience with program change management practices, lean or six sigma, program and system integration effort.