Job TitleData Analyst
Job Responsibilities:
- Executes low complexity post market surveillance processes, adheres to predefined parameters and guidelines, optimizes efficiency and effectiveness, and fosters consistency and reliability in operations to maintain a high level of quality and performance within the established framework of operational procedures.
- Conducts operations and reporting procedures to ensure efficient tracking and monitoring of execution progress, enabling effective decision-making and resource allocation aligned with strategic goals.
- Develops and delivers comprehensive reporting tools to facilitate informed decision-making and performance evaluation across the organization, enabling proactive management and strategic planning initiatives.
- Collaborates closely with business process experts to execute comprehensive training initiatives, delivers effective training programs tailored to meet the specific needs of the organization, and fosters skill enhancement and knowledge transfer across various business processes.
- Conducts quality assurance assessments on developed communication tools, ensures that the tools meet stringent standards for precision and efficacy and evaluates their accuracy in reporting and effectiveness in generating response plans.
- Gathers and merges data from diverse sources, consolidating it into a cohesive and actionable perspective to provide a comprehensive view that enables informed decision-making and facilitates effective implementation of strategies and initiatives across the organization.
- Documents and maintains meticulous records of post-market surveillance activities to ensure accuracy, compliance, and accessibility for monitoring product safety and facilitating timely responses to emerging market trends.
- Compiles and analyze continuous product performance data to identify any safety issues, performance deviations, or trends that may require further investigation.
- Supports the preparation of post-market surveillance documentation, ensures adherence to regulations and guidelines, and collaborates with clinical affairs and stakeholders to compile necessary documentation, such as post market surveillance plans and reports.
Minimum Required Education
Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
You're The Right Fit If
- You have a minimum of Bachelor's degree in Life Sciences, Biomedical Engineering, or a related technical field.
- You have 4-8 years' experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with a focus on post-market surveillance plans/reports and post market risk assessment - Mandatory
- You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc - Mandatory
- You have excellent communication (written and oral) and stakeholder management skills, with the ability to influence at all levels.
- You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, quality and compliance.
- Product Knowledge on Diagnostic X-rays is preferred.
Preferred Skills
- Device Recall Procedures
- Post-Market Surveillance Mechanisms
- Quality Management Systems (QMS)
- Regulatory Requirements
- Technical Documentation
- Project Management
- Training Delivery
- Quality Assurance (QA)
- Business Intelligence Tools
- Data Management
- Business Acumen
In return, we offer you
At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services.
How We Work At Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our Hybrid Working Model Is Defined In 3 Ways
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
