Sr. Regulatory Affairs Specialist
hace 2 semanas
Job Title:
Sr. Regulatory Affairs Specialist
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.
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.
Job OverviewEstablish, maintain and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent Authorities
Responsibilities
- Seek out and evaluate changes to standards and regulations affecting Philips Image Guided Therapy Corporation products. Define and maintain the process needed to keep the relevant team and supervisors informed about potential impact products and their respective QMSs throughout the products lifecycle.
- Responsible for project management specific to ensuring that applicable medical device standard or guidance are understood and properly implemented within the Philips Image Guided Therapy Corporation QMS. Maintains project data necessary to understand assumptions made, progress made, and issues or risks associated with the projects. Organizes the archives of project information. Teaches project stakeholders how to effectively access information to help drive appropriate decisions.
- Trains Costa Rica site personnel on the responsibilities and functions of the Regulatory Affairs department and interacts with the different areas to foster a unified way of working.
- Supports Audits by providing active support and collaboration to the front and backroom audit team
Requirements:
- Bachelor's degree in a technical discipline such as Science, Industrial Engineering, or Law or a combination of equivalent job experience in related field.
- Minimum of 35 years of experience in the medical device or pharmaceutical industry and technical environment.
- Must have experience with preparation and submission of international documents or registration and marketing of medical device worldwide.
- Strong background in design controls.
- Excellent working knowledge of medical device regulations (21CFR, ISO 13485), FDA Law, MDR, other global laws and regulations.
- Experience in supporting international registrations.
- Advanced English
- Administrative Shift
In return, we offer you
- In order to develop your full potential, we will offer you the flexibility, encouragement and opportunities to keep you inspired and engaged. After all, working at Philips is more than a job. It is an experience full of amazing moments that will transform you in a lasting and positive way, since together we can improve the world.
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.
LI-PH1
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