Philips Post Market Surveillance Lead 

United Kingdom, England 

303493535

Post Market Surveillance Lead
Job Description

Contract Type:12 month Fixed Term Contract

As the Field Actions Lead, you will be a key representative in strategy planning of Field Safety Corrective Actions (FSCA / Correction & Removals) representing the International Markets. You will actively take part in the planning activities with the legal manufacturer, and other functions prior to initiation.

In this role, you will have the opportunity to:

• You will be supporting and coordinating the International Markets region in the participation of Business & Market Correction and Removals Review Board meetings and provide market feedback to ensure consistent decision making across Philips Businesses and Markets.

• Identify potential reportable and/or safety related C&R, ensuring that the Markets C&R teams are reporting to relevant Competent Authorities within prescribed timelines, and mechanisms for timely customer follow-up and response.

• Ensures that processes for specifying and executing C&R are adequate to ensure the expectations of all key stakeholders are met.

• Partner with Businesses to identify Corrections and Removals (C&R/ FSCA) that require escalations to the Global Executive Corrections and Removals Review board as part of the C&R Management team. Reinforce and improve the standard way of operating for Philips Corrections and Removals process across the Markets.

• Partner with businesses, markets, 3rd party Legal Manufacturers, to understand and mitigate risks related to timely and effective field action processes, as well as driving continuous improvement initiatives.

• Support in monitoring systems for daily management overview of C&R activities across International Markets

• Provide real-time support of the Post Market process during audits in collaboration with the Local Process Owners.

To succeed in this role, you’ll need a customer-first attitude and the following:

• A Bachelor’s in engineering or science degree
• Significant related experience in medical device / pharma industry is required.
• Experience or exposure in Post Market Surveillance (PMS) is required and field action activities are preferrable.
• Background /Experience with global medical device regulations, requirements, and standards such as ISO13485, ISO9001, MDD, European Medical Device Regulation (MDR), FDA QSR .
• Ability to move strategy into action, drive decisions while effectively communicating detailed information and strategic decisions to project team members of all levels.
• Fluent in English.
• Experience in driving key initiatives or processes in a global, matrixed organization.
• Must possess a strong customer focus with doing things right the first-time approach and demonstrate high-performance behaviour of shared accountability.