Minimum required Education:
Bachelor's Degree in any Engineering, Biomedical Engineering.
Minimum required Experience:
Bachelor's Degree with 6+ years of experience in Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent.
Minimum required Certification:
N/A
Job title:
Regulatory Affairs Specialist
Your role:
Be recognized as a key talent in International Regulatory filings and procedures.
Be considered a key regulatory point person in Centralization of Regulatory Operations and enable the regulatory compliance in Markets where Philips products are commercialized.
Be an impactful member of the Regulatory Affairs (RA) team and trusted by management as an independent regulatory team member on multiple projects simultaneously.
Assist in building center of excellence for RA operation with purpose to centralize regulatory operations to enhance compliance, efficiency, and global market readiness.
Function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines.
You're the right fit if: (4 x bullets max)
1. Experience- 6+yrs of experience in international regulatory affairs
2. Skills- Regulatory Affairs, Dossier Preparation, experience in Class, I, II.
3. Education- Any Engineering Degree, prefer in Biomedical Engineering
4. Anything else- Good Interpersonal skill, holding strong communication skills.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
Over the past decade we have transformed into a focused leader in health technology.
At Philips, our purpose is to improve people’s health and well-being through meaningful innovation. We aim to improve 2.5 billion lives per year by 2030, including 400 million in underserved communities.
We see healthcare as a connected whole. Helping people to live healthily and prevent disease. Giving clinicians the tools they need to make a precision diagnosis and deliver personalized treatment. Aiding the patient's recovery at home in the community. All supported by a seamless flow of data.
As a technology company, we – and our brand licensees – innovate for people with one consistent belief: there’s always a way to make life better.
Visit our website: http://www.philips.com/
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