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Regulatory Compliance Manager

Req ID: J2251615

  • Location
    Horseheads, United States of America
  • Category Quality Group
  • Posted Friday, October 16, 2020
  • Type Regular Full time

Job Description

JOB SUMMARY

This position has the responsibility and authority to lead assigned Quality System processes. In addition this role will lead internal audits, customer audits, ISO Registration audits, FDA Inspections and when required prepare submissions and responses to FDA and ISO Registrars. This position will serve as the primary contact for site departments, business units, and corporate functions and will work closely with direct reports to provide guidance and development opportunities.

ESSENTIAL DUTIES AND RESPONSIBILITIES


·       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

 



JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS

·         Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)
·         Some experience with compliance assessments, gap assessments and risk management assessments.
·         Experience with program change management practices, lean or six sigma, program and system integration efforts
·         Strong computer skills; Word, Excel, PowerPoint
·         Strong interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally.
·         Strong leadership, collaboration and relationship building skills. Must be able to work in a team environment, influence change without alienating others.
·        
EDUCATION & EXPERIENCE REQUIREMENTS

·         Bachelor’s degree required (Quality, Regulatory, Engineering, Business or Life Sciences)
·         Master’s degree is desired (Quality, Regulatory)
·         6 + years of industry experience within Quality and/or Regulatory, and managing high performing teams.

·       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 efforts

·         Or a combination of education, experience and/or training.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.

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