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Regulatory Affairs Specialist 3
at Philips Electronics North America Corporation in Foster City
Philips Medical Systems
A leader in Healthcare, Philips Medical Systems is one of the world as top three medical device companies. Our mission is to improve the quality of people as lives.
Our focus areas include imaging systems, customer services, information and monitoring systems. We enjoy a number one position in several of these including X-ray, cardiovascular ultrasound, patient monitoring and automatic external defibrillators. Our HeartStart Home Defibrillator brings life-saving technology to consumers in their own homes, where the majority of sudden cardiac arrests occur. It as just one of the many ways we deliver ‚¬Ëœadvanced a technology that is ‚¬Ëœdesigned around you a and ‚¬Ëœeasy to experience a.
Quality & Regulatory
Your Responsibilities:
Provide regulatory support and guidance for new product development and sustaining engineering programs. This includes preparation of project regulatory strategy documentation, 510k & technical file submission activities, project team guidance for product regulatory and compliance requirements. 40%
Support Quality & Regulatory (Q&R) department via sustaining Q&R functional requirements such as participating in internal & external auditing programs, review and approval of sales and marketing product literature and labels, product IFUs...etc., assistance with vigilance & MDR reporting requirements including the performance of health risk assessments and product complaint mitigation. 40%
Other departmental and business support activities including support and facilitation of compliance training requirements, documentation review and approval, and other typical day-to-day activities. 20%
Your Profile:
The successful candidate will possess a minimum of 3-years direct quality and regulatory experience within a software or related technology medical device company, while serving in a capacity of performing regulatory activities as previous described.
The successful candidate will possess a 4-year college degree from an accredited institution in the fields of english, computer science, or other technical competency requiring strict attention to detail.
Preferred skill set includes both US RAC and European RAC credentials, certification via ASQ as a certified biomedical quality auditor or CQE. Candidates must possess very strong interpersonal and communication skills, and good computer skills such as MSWORD, EXCEL, PowerPoint...etc.
Contacts:
Philips
Notes
Philips is an equal opportunity employer.
Eligible for an employee referral bonus of Simplicity Rewards points.
A leader in Healthcare, Philips Medical Systems is one of the world as top three medical device companies. Our mission is to improve the quality of people as lives.
Our focus areas include imaging systems, customer services, information and monitoring systems. We enjoy a number one position in several of these including X-ray, cardiovascular ultrasound, patient monitoring and automatic external defibrillators. Our HeartStart Home Defibrillator brings life-saving technology to consumers in their own homes, where the majority of sudden cardiac arrests occur. It as just one of the many ways we deliver ‚¬Ëœadvanced a technology that is ‚¬Ëœdesigned around you a and ‚¬Ëœeasy to experience a.
Quality & Regulatory
Your Responsibilities:
Provide regulatory support and guidance for new product development and sustaining engineering programs. This includes preparation of project regulatory strategy documentation, 510k & technical file submission activities, project team guidance for product regulatory and compliance requirements. 40%
Support Quality & Regulatory (Q&R) department via sustaining Q&R functional requirements such as participating in internal & external auditing programs, review and approval of sales and marketing product literature and labels, product IFUs...etc., assistance with vigilance & MDR reporting requirements including the performance of health risk assessments and product complaint mitigation. 40%
Other departmental and business support activities including support and facilitation of compliance training requirements, documentation review and approval, and other typical day-to-day activities. 20%
Your Profile:
The successful candidate will possess a minimum of 3-years direct quality and regulatory experience within a software or related technology medical device company, while serving in a capacity of performing regulatory activities as previous described.
The successful candidate will possess a 4-year college degree from an accredited institution in the fields of english, computer science, or other technical competency requiring strict attention to detail.
Preferred skill set includes both US RAC and European RAC credentials, certification via ASQ as a certified biomedical quality auditor or CQE. Candidates must possess very strong interpersonal and communication skills, and good computer skills such as MSWORD, EXCEL, PowerPoint...etc.
Contacts:
Philips
Notes
Philips is an equal opportunity employer.
Eligible for an employee referral bonus of Simplicity Rewards points.
» Apply now
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