vor 9 Tagen

Manager Regulatory Compliance - Medical Devices

Abbott

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Abbott  is about the power of health. For more than 125 years,  Abbott  has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health

Thoratec Switzerland GmbH is an Affiliate of Abbott Medical and takes care of the development and manufacturing of our mechanical circulatory support devices, that are designed to support a broad range of advanced heart failure patients. To complete our team, we are looking for a

 

Regulatory Compliance Manager

In this Manager position you:

  • Analyze aspects of and executes quality-assurance activities to ensure compliance with internal procedures and external standards and regulations.
  • Lead and guides the activities of the Quality organization with responsibility for results in terms of product quality, performance, and safety.
  • Provides guidance, support and communication with Operations, R&D/Engineering, and customers to resolve quality issues and other related product concerns.
  • Conducts projects and provides support and communication with Operations and R&D/Engineering to achieve successful closure.
  • Actively drives all defined Quality Systems goals and objectives at the plant level.
  • Leads groups in functional and staff manner.

 

Main Responsibilities

  • Manages and leads groups of quality specialists (up to 10), sets individual goals derived from company goals and objectives and other (regulatory) requirements and supports personnel to meet the goals. Takes responsibility in assigning tasks and allocates resources where needed to achieve these goals. Monitors and guides personnel to ensure efficient, accurate, and compliant work of personnel.
  • Responsible for the training, performance management, and supervision of quality staff for the Zurich, Switzerland facility to meet company requirements. Identifies resource needs to provide coverage to support operational activities.
  • Maintains up-to-date knowledge of national and international (especially USA and European) quality-system regulations and standards. Evaluates and assures facility-wide compliance with all applicable quality systems standards and regulatory requirements by planning and executing tasks necessary to meet these requirements. Prepares facility for inspections and interfaces with outside regulatory agencies during regulatory inspections. Supports the facility in internal quality audits carried out by the company. Trains company employees in compliance topics.
  • Manages the document control system including maintaining the Document Control Order (DCO) System, maintaining DCO files including pending, closed and archived files.
  • Analyzes and reports quality metrics and trends for key quality indicators to assist company management in decision-making process.
  • Assists in the development and administration of quality assurance procedures and activities to ensure products and processes are in compliance with quality standards and regulations. Develops the quality system by implementing best practices.
  • Supports product acceptance activities. Reviews production records to ensure compliance of documentation and related processes, and makes final decision on the release of accepted product.
  • Oversees the evaluation and disposition of non-conforming product and processes identified during production or other quality-relevant processes. Participates in root-cause investigations related to (internal) customer complaints. Analyzes and and escalates issues in a timely fashion.
  • Reviews the analysis of returned products from Customer Complaints in order to determine root causes and if need be corrective action. Initiates disposition of returned complaint material including rework, repair or scrap decisions. Supports submissions to regulatory agencies (MDR/Vigilance system).
  • Analyzes systematic trends related to non-conforming products or processes in order to determine root causes, and if need be, corrective and preventive actions. Takes ownership in resolving quality issues following the CAPA process.
  • Participates in design review and document release related to products, tools, and processes. Ensures rationales and applies statistical techniques in order to guarantee compliance with regulations.
  • Participates in the assessment of new suppliers focusing on review of quality requirements. Participates in the performance of on-site supplier assessment and audits.

 

General.

  • Works closely and proactively with the Manager Quality to maintain and to improve the quality system, it’s integration with company wide quality systems and alignment with all applicable standards and regulations
  • Works closely and proactively with Regulatory Affairs in submissions, e.g., by providing technical information.
  • Organizes and moderates projects related to quality and ensures on time and in budget completion.
  • Supports other departments as quality specialist in non-quality related projects.
  • Travel for company business or training purposes to fulfill designated tasks might be required.
  • Performs other duties as assigned by the Quality Director
  • Can act as backup for Manager Quality.

  

Your profile

  • Master’s degree in science, Engineering or another Technical field is required.
  • Three to five years of related experience in a medical device manufacturing environment.
  • In-depth knowledge of ISO, European and US regulations related to medical devices
  • Experience in supervisory position.
  • Comprehensive understanding of international and domestic medical device regulatory guidelines.
  • Proficiency with personal computers, business and technical software.
  • Strong math, problem solving, and decision-making skills.
  • Very professional and effective verbal and written communication skills (English and German).
  • Can work self-organized as well as with remote organizations (US facilities)
  • Excellent organizational, time management, and multi-tasking skills.
  • Ability to work in a team environment using effective interpersonal and negotiation skills.
  • High ethical standards and can get things done.

 

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your online application as pdf .