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Sr. Regulatory Compliance Manager (Medical Device)

Req ID: J2279188

  • Ubicación
    Elmira, NY, Nueva York, United States of America
    Monumento, CO, Colorado, United States of America
    Remoto - Estados Unidos, Florida, United States of America
    West Chester, Pensilvania, United States of America
  • Categoría Grupo de Calidad
  • Publicado miércoles, 14 de julio de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

Overall responsibilities

This position has the responsibility and authority to lead a regional team to ensure planning, preparation, execution and follow up of internal audits, supplier audits, customer audits, certification body audits, FDA or other country authority inspections and when required prepare submissions and responses to FDA, other country authorities and certification bodies. This position will serve as the primary contact for regionally shared departments, business units, and functions and will work closely with direct reports to provide guidance and development opportunities.

Position duties and responsibilities

  • Be the Champion and subject matter expert for the Quality Systems and Compliance programs.
  • Ensure the region’s quality system development, effective maintenance and continued compliance with business unit requirements, medical device regulations and standards (e.g., 21 CFR, ISO 13485)
  • Supervise department activities within the Regulatory Compliance function (i.e., Supplier Audits, Internal Audits, Customer Audits, 3rd Party Inspections and Inspection Readiness)
  • Lead the follow-up, negotiation and resolution of issues resulting from 3rd party or customer audits
  • Continue to develop and enhance current regulatory knowledge in the region to support surveillance activities
  • Act as interface to regional Quality and/ or Operations team
  • Facilitating a strong connection to the other leaders of the global Regulatory Compliance team incl. best practice and lessons learned sharing, harmonization of processes
  • Responsible for proposing and supporting Quality System improvement opportunities
  • Responsible for reviewing and where needed initiating the update of Regulatory Compliance processes and procedures in accordance with customer and regulatory requirements
  • Establish, maintain, and report Regulatory Compliance metrics to regional level teams, management and global business units
  • Support the effectiveness of the Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes
  • Manage expenses; provide support to budget planning, scheduling, and site wide process improvement opportunities
  • Perform 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 profile
 

Education Requirements:

  • Bachelor’s degree required (e.g. Quality, Regulatory, Engineering, Business or Life Sciences)
  • 6+ years of industry experience within Quality and/or Regulatory and managing high performing teams
  • Or a combination of education, experience and/or training

Experience & Skills:

  • 7-9 years` expertise in understanding and interpretation of international medical device quality system regulations, standards and best practices (e.g.21 CFR 820, ISO 13485)
  • 7-9 years’ experience with compliance assessments, gap assessments or risk management assessments
  • 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.
  • Must have a high tolerance for ambiguity
  • English Business fluent

The anticipated pay range for this role is $93,784 - $135,795 - $177,913. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.

As part of the total rewards package, this position is eligible for a short-term incentive based on performance. In addition, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purpose plan; and paid time off.

This job cannot be performed remotely in the state of Colorado.
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