Post Market Surveillance Specialist

Corrections & Removals Specialist (Randstad Contingent Worker)

This position will be fully remote and can be home-based from anywhere in the US.  

In this role, you will have the opportunity to:

The Correction and Removal (C&R) Specialist will help manage the execution of the correction and removal process.

You will be responsible for:

The C&R Specialist will primarily be responsible for

• Driving progress of action items with support and sponsorship from leadership for reportable corrections and removals.

• Managing regulatory agency updates as required. Specifically, coordinating monthly status reporting to various Regulatory Bodies (FDA, Competent Authorities, Notified Body, etc.). It is expected the C&R Specialist has adequate experience to validate and combine multiple data sources to build these reports.

• Synchronizing status reports with the international team with the interest of harmonizing Competent Authority reports, globally

Other areas of responsibility include:

• Managing C&R responses, C&R file documentation and C&R file completion.

• Continuously tracking and provide ongoing information to C&R/FCO team as required.

• Monitoring and reporting on metrics on the efficacy of C&R process.

• Providing ongoing information to C&R and FCO team as required.

• Submitting MDR/MIR, FSN Communication to the competent authorities and or other regulatory agencies as required by country/market.

• Monitoring KPIs and escalating when needed to ensure timely closure.

• Review field communications, service instructions, engineering change notices to determine if any actions may constitute as a correction or removal that requires

• Following-up with customers/distributors for devices subject to FDA Tracking orders

To succeed in this role, you should have the following skills and experience:

• 4-6 years post-market surveillance recall experience in a medically regulated industry.

• Bachelor’s degree in engineering, clinical sciences, related sciences, or relevant related experience.

• Proficiency using office tools such as Microsoft Office Suite and various other computer software applications.

• Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR. Medical Device and or other regulated industry (Pharma, IVD,).

• An organized, analytical thinker with exceptional attention to detail.

• An excellent communicator, both written and verbal for coordinating with colleagues and regulatory authorities worldwide.

• Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.

You will be a part of:

The Respironics Team is headquartered out of Pittsburgh, PA. We welcome you to join Philips HealthCare. The Quality and Regulatory team enables meaningful innovation for our customers by partnering with and guiding the business to achieve world-class quality and regulatory compliance in a rapidly changing environment, while creating a great workplace for our people to realize their career aspirations.

In return, we offer you:

Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.

Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.