Director, Quality & Regulatory
In this role you will be responsible for ensuring business continuity while building the new working model for our RFRC business.
You are responsible for
Crafting, developing, and implementing a new working model for the RFRC business as part of project Wolf (i.e. legal manufacturer design, delegations, oversight models, and footprint required to ensure sustainable execution).
Establishing and owning the Q&R Wolf Governance model:
Leading, in partnership with Pune (India), the Business Quality actions related to project Wolf, while ensuring that other matrixed quality functions have clarity in their scope of accountability and deliver on their commitments.
Driving resolution to project related issues, ensuring appropriate communication structure is in place with partners.
In parallel to project Wolf, this role will also represent Imaging Components in strategy development, decision making, and ensuring execution related to the business split between Imaging Components and DMS.
Effectively handling interdependencies between Wolf, the DMS split, and EU MDR
Enabling the vision for the Imaging Components Q&R team.
Influencing business partners and encouraging the organization to ensure the EU MDR committed timeline is met/exceeded.
Acting as site management representative for all key regulatory agencies for product safety and quality.
Actively ensuring the Gainesville RFRC business is in a constant state of audit readiness.
Leading and driving effective deployment of the Philips Excellence Process Framework and Quality Management System
Providing leadership and direction to the Q&R organization in support of the RFRC business (part of Imaging Components Business Category).
Implementing an effective local governance structure that drives accountability, ensures detailed execution, and drives rapid issue resolution to enable compliant business performance.
To succeed in this role, you should have the following skills and experience
Bachelor’s, Master’s, or PhD in a technical discipline.
10+ years of regulated industry experience
Business sense and strong business partnering skills
Effective communicator and relation builder/networker
Willing to travel up to 25%
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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.
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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