Sr. Clinical Post Market Surveillance Specialist

Sr. Clinical Post Market Surveillance Specialist (Randstad Contingent Worker)

REQUIRED: Licensed Respiratory Therapist

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

In this role, you will have the opportunity to:

In this role you will support post market activities and other quality tasks for the Hospital Respiratory Care business unit. These activities focus on the process for global medical device reporting to competent authorities and includes review and evaluation quality complaints for fielded product which may represent reports of adverse events and/or critical device malfunctions and timely processing of the reports required for compliance to global regulations and standards. The role further supports general post market surveillance activities including timely closure of complaint records, process optimization, data analytics, and the development and implementation of solutions to meet the changing needs of a dynamic regulatory environment.

You will be responsible for:

Complaint Handling with focus on Clinical Review in accordance with global regulations and standards. Timely complete and file global medical device reports. Identify and escalate issues potentially impact Risk Management Files. Support a quality culture of continuous improvement. Provide general clinical support and expertise.

Primary Responsibilities (What is the main purpose of the job):

Support the global medical device reporting process for the Hospital Respiratory Care business by completing the following:

Performing initial review of complaint records to determine if reports represent information which may be reportable to one or more global competent authorities

Identifying complaints that may be reportable as adverse events or those needing further review or investigation

Completing detailed adverse event reporting decisions including detailed evaluation of device malfunctions and reported patient outcomes

Timely complete and file medical device reports in accordance with global regulation and time frames

Team with Philips Market Groups globally to ensure local medical device reports are timely filed with local regulators

Generate complete and robust quality records.

Investigate and document specific elements and circumstances involved in a complaint. Critical elements of the complaint recorded

Assess accuracy and completeness of service findings and associated coding. Working with domestic and international service organizations to resolve open issues.

Support closure of quality and non-quality complaints

Working with customers, sales & marketing, engineers, and others to investigate and address customer and regulatory inquiries

Preparing and filing written response to competent authority inquiries. All responses will be completed and filed within the time specified by the requesting agency

Perform other QA related duties on an as needed basis to support department objectives and business needs

Consistently apply established device Risk Management File decisions individual complaint investigations for medical devices. Identify and escalate issues not represented in established Risk Management Files

Enable a culture of continuous improvement by identifying individual opportunities for improvement and delivering results using LEAN concepts

Perform other QA related duties on an as needed basis to support department objectives and business needs.

This includes:

Generate quality data for analysis, management review or in support of other objectives.

Generate and conduct DORSI reviews for Leadership

Support internal / external audits and field actions as necessary.

Support corrective and preventive action activities for both product and process related issues.

Interpret a diverse set of global regulations for quality systems and regulatory requirements and apply to dynamic situational needs in post market surveillance

Maintain compliance with quickly evolving global post market surveillance regulations and standards

Assignments are broad in nature, usually requiring appreciable originality and ingenuity.

Using your clinical expertise, manage patient-involved, regulatory reportable cases and escalate to Leadership per established guidance

Drive continuous process improvement to meet challenges in changing regulations and increasing process demands

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

Required Experience:

Bachelor's degree OR relevant two-year degree with 6+ years working in a health-related position.

Licensed Respiratory Therapist, Registered Nurse, PA-C, or MD with 2+ years working in a clinical environment.

Demonstrated familiarity with statistical analysis concepts and techniques, quality methods, tools, and concepts.

Demonstrated, excellent analytical, investigative, and clinical writing skills.

Medical device/Life Science Industry experience with familiarity in quality complaint handling and Quality Management Systems.

Preferred Experience:

Experience interfacing directly with FDA or other regulatory agencies is preferred.

Experience in conducting complaint investigations including adverse event reporting in a global environment.

Key Abilities:

Success in this job will depend highly on demonstrating the following behaviors:

Customer first attitude

Quality and integrity always mindset

Propensity for teaming up to drive successful outcomes

Taking ownership of key responsibilities and delivering fast

Eagerness to continuously improve and inspire others

Ability to work effectively in both an individual and team environment with minimum supervision, conferring with supervisor as needed.

Excellent written and verbal communication as well as interpersonal skills

Strong technical writing skills

Must have high degree of flexibility and high comfort level while working on many tasks in parallel

Must employ clinical expertise in quickly assessing individual complaints for global medical device reporting requirements

You will be a part of:

An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.

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.