Manager Post Market Surveillance Manager

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I am currently recruiting for an exciting new position with a leading medical device company located in Westmeath for a International Post Market Surveillance and Global Field Corrective Action Senior Manager.

This is a 3 year Fixed term contract with excellent salary and benefits.

You will be responsible for monitoring, understanding and managing product quality customer complaints received by the company. Responsibility for adverse event reporting. You will also manage Global Field Actions and will oversee a team.

What will I be doing ?

* Management of Medical complaint handling, vigilance reporting and field safety corrective action systems and ensuring same is compliant with current regulations.

* Development and provision of a harmonized complaint reporting and management system in International including:

* Streamline complaint handling & vigilance processes across International.

* Support implementation of an integrated complaint management IT system across International.

* Development of complaint & vigilance metrics to International Senior Management.

* Conduct Complaint Handling Training to International Sales & Marketing, Customer Service & distributor companies as required.

* Root cause analysis improvement and standardisation of complaint investigation reports across manufacturing sites.

* Coordinate complaint follow-up and completion of appropriate corrective actions.

* Manage the coordination of Global Field Safety Corrective Actions.

* Support for the risk management process, provision of complaint data to risk management process to allow the files to be maintained as current.

* Maintain close working relationships with Regulators and Notified Bodies Globally.

* Managerial responsibility for Post Market Surveillance personnel. Development of direct report KPIs and goals and objectives and the regular review of same.

* Support the expansion and enhancement of post-market surveillance activities as it develops.

* Maintain close working relationships with complaint handling and vigilance group.

What you need to apply for the role?

* Engineering/Science qualification with 5 years of working within complaints in a medical device environment.

* Proven experience as an effective Post Market Surveillance & Field Corrective Action Senior Manager in the Medical Device Industry. Experience interpreting legislation and legal documents and applying them to business.

* Proven ability to work in a team and provide expertise.

* Excellent technical writing experience within a medical device environment essential.

* Knowledge of Quality and Regulatory requirements and regulations including but not limited to FDA's 21 CFR Part 820 (Quality System Regulation), ISO 13485 Quality System requirements, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV, Canadian Medical Device Regulations, Japanese JPAL requirements.

* Good working knowledge of the Quality System Regulations as they pertain to Post Market Surveillance & Field Corrective Action activities.Experience with bio-hazard management/contamination control preferred

* Attention to detail and accuracy essential

* Ability to work well under deadlines and pressure

* Problem solving skills for developing creative solutions and meeting objectives are required.

* Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);

* Excellent analytical ability

* The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.

* Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.

* Good business acumen.

If you meet the above requirements and are interested in hearing more don't hesitate to apply or contact me on 01 888 3477. Don't miss out on this opportunity to become part of a leading company going through an exciting growth phase. Please respond with an updated CV.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales