In this role, you have the opportunity to
Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submission.
Be a part of team of build a high growth business that will help improve the lives of millions of patients, while advancing Philips digital transformation journey as a global leader in Health Technology.
You are responsible for
Create regulatory plan using Regulatory Intelligence and in collaboration with region/country RA to ensure all requirements are met for country submissions;
Through upfront collaboration with Philips Subject Matter Experts, clearly outline China type testing regulatory requirements and support Type Testing activities to ensure timely execution;
Actively participate as a team member on all assigned projects supporting Philips devices;
Create and file submissions; Communicate with authorities regarding these submissions;
Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products;
Review changes in existing products to determine need for new/revised submissions or document reason for no submission;
Facilitate testing and inspection from NMPA, ETL, CSA, TUV and other regulatory agencies;
You are a part of
You are a part of Philips Ultrasound Regulatory Affairs Organization with a global footprint. You will report to China Philips Ultrasound Regulatory Affairs Leader. The Regulatory Affairs team is multicultural and are enthusiastic professionals that work as a team to ensure regulatory compliance.
To succeed in this role, you should have the following skills and experience
Bachelor’s Degree & minimum of 6 years’ experience in the medical device industry or with medical product regulatory agencies.
Significant knowledge of all relevant China regulatory requirements and experience in clearly outlining end to end China Type Testing Strategy, facilitation, and extremely well rounded technical negotiation skill sets are a must have
Ability to prioritize, plan & evaluate deliverables to established strategic goals.
Proven application of analytical skills in a regulatory environment.
Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English.
Demonstrated knowledge & experience conducting scientific, regulatory or business research.
Strong problem solving and negotiation skills
Ability to work well independently & in a team setting
Knowledge of Quality Management Systems (QMS)
Demonstrated experience interfacing with key regulatory agencies globally (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL