Post Market Surveillance Consultant
Post Market Surveillance Consultant (Randstad Contingent Worker)
This position is remote and can be home based anywhere in the U.S.
In this role, you will have the opportunity to:
Support the Corrections & Removals (also referred to Field Actions, Recalls, FCO’s, FCA’s) processes for IGTD including initiation, customer and regulatory notifications, product correction or removal, effectiveness checks, monthly updates, and termination with Competent Authorities.
You will be responsible for:
- Working with cross-functional team to support development of required documentation of field actions
- Assist with preparation of customer letters, field action status reports, and communications to regulatory agencies and competent authorities for field actions
- Support Issue Impact Assessments (IIAs) and Health Hazard Evaluations (HHEs) to ensure risk assessment and analysis are consistent across products and systems within IGTD
- Complete activities in alignment with Corrections & Removals strategies.
- Assist with internal communications for Corrections & Removals activities, including communications for senior company management, corporate law, corporate communications, service markets, and distribution partners
- Maintain electronic records of Corrections & Removals activities, including consignee lists, units affected lists, communications with regulatory agencies, Field Safety Notice deliveries, receipt of customer responses, status reports, and record closure.
- Continuously tracks Corrections & Removals, providing ongoing information to the team as required
- Reports metrics on the efficacy and efficiency of Corrections and Removals processes
- Timely submission of Corrections and Removals KPIs for IGTD
To succeed in this role, you should have the following skills and experience:
- Bachelor’s degree in healthcare or science fields
- 3+ years of Quality and/or Regulatory experience in the medical device industry
- Strong written and oral communication skills are required
- The ability to work well independently and on many teams in a demanding department while managing multiple ongoing tasks, investigations, and projects simultaneously
- The ability to work as an individual contributor in a fast-paced, changing environment, to meet deadlines
- The ability to manage multiple tasks, continually prioritize and meet deadlines in a timely manner
- Strong problem solving and analytical skills with attention to detail is required.
- Must have proficient computer skills such as MS Word, Excel, PowerPoint
- Ability to perform data analysis/analytics related to MS Excel is desired
- Strong organizational, communication, and follow-up skills required
- Experience with Trackwise, SAP, Windchill, and/or OneEMS/Salesforce preferred
- Experience working in a broader enterprise/cross-division business unit model preferred
- Working knowledge of appropriate global medical device regulations, requirements, and standards preferred, such as 21 CFR Parts 803, 806, and 820, ISO13485, European Medical Device Directive (93/42/EEC), European Medical Device Regulation (EU MDR 2017/745 EU) Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, Brazilian Resolution RDC 23, and Therapeutic Goods Act 1989.
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.