Director of Post Market Surveillance & Complaint Handling

Job Title

Director of Post Market Surveillance & Complaint Handling

Job Description

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation. *Montana employees are currently excluded from this requirement at this time.

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.

The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better:

Exciting strategic leadership opportunity focused on driving the Image Guided Therapy-Devices (IGTD) Complaint Handling, Post Market Surveillance, and Corrections & Removals programs. Your contributions will play an important role in improving and saving lives around the world.

You are responsible for:

• Provide feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations.

• Representing the company with regulatory agencies during external audits.
• Appointment as IGTD Person Responsible for Regulatory Compliance (PRfRC) ensuring post market surveillance and reporting obligations.
• Leading and setting strategy for the corrections and removals process for IGTD including initiation, customer and regulatory notification, and product withdrawal
• Leading and setting strategic direction for Complaint Handling Program for IGTD.
• Developing Quality team personnel to meet current and future quality, customer, business and regulatory requirements. Support professional development plans of team members.
• Notifying senior company management, corporate law, corporate communications and other internal stakeholders of corrections and removals including markets and distribution partners.
• Coordinating Corrections and Removals and communicate with government regulatory agencies and maintain records of actions taken.
• Ensuring team conducted proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions.
• Ensure that processes for executing complaint handling and corrections & removals are compliant to global regulatory requirements and meet internal quality system requirements.

You are a part of:

Philips Image Guided Therapy-Devices (IGTD) solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Heart Rhythm Management.

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

• Minimum of a Bachelor's Degree in Science, Healthcare or Engineering discipline (preferred), Master's Degree desired.
• Minimum of 10+ years' experience working in FDA regulated medical Device/HealthTech environments, with a focus in Complaint Handling, Post Market Surveillance (PMS), and Corrections & Removals programs.
• Minimum of 5+ years' experience in functional/strategic team leadership.
• Detailed knowledge of appropriate global medical device regulations, requirements, and standards, 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.
• Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
• Problem-solving and proficient computer skills are required. Proficiency in MS Word, Excel, PowerPoint, and Outlook.
• Ability to provide guidance to multiple facilities supporting Complaint Handling processes
• Ability to leverage and/or engage others to accomplish projects
• Experience working in a broader enterprise/cross-division business unit model preferred
• Ability to work in a matrixed and geographically diverse business environment
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes, and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to travel approximately 10%, potentially internationally

* US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

In return, we offer you:

We offer you the rewarding opportunity to grow within the IGTD organization and Philips - working cross functionally with R&D, on various projects and initiatives to drive our products to our customers and be a part of saving people's lives every day.

How we work at Philips:

There are three core ways that define our ways of working - embracing flexibility, being at our best, and impactful collaboration. We believe this enables us to deliver an outstanding experience to our customers and create the best place to work for people who share our passion.

We know just how important direct interactions are and work is more engaging when we are more frequently face-to-face, and that we experience better collaboration which drives innovation. While we have many different types of roles across Philips most require a combination of in-person collaboration with colleagues and partners, usually at a Philips location, and individual focus time, which can be done remotely.

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 improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.