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 China Local and 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
Manage regulatory project efficiently and independently.
Compile PTR and Drive type testing independently
Actively participate as a team member on all assigned projects supporting Philips Ultrasound devices;
Create regulatory plan using Regulatory Intelligence and in collaboration with region/country RA to ensure all requirements are met for country submissions;
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;
Facilitate testing and inspection from NMPA, Local FDA and other regulatory agencies;
Perform gap analysis on NMPA requirement and propose solutions;
Provide regulatory guidance and solution to field where RA input are required.
Drive domestic device registration, support imported device registration as needed.
Drive RA related program and projects internally.
Maintain regulatory files and tracking databases as require
Country-specific labelling Implementation or other requirements from global markets
Drive the Consular attestation or support key market RA team on global registrations
Communicate application progress with relevant stakeholders
Review and approve product files or other internal process in prospective of regulatory compliance
Support VS`s partners on transducer.
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 Lead. 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 or above in related scientific discipline; Medical, pharmaceutical, bioscience and engineering background is preferred
Regulatory experience in active device is must, with 5+ years` experience.
Both ClassII and ClassIII experience are preferred
Have a sound understanding of NMPA registration
Team player with eager learn and open mind
Able to identify compliance risks independently and escalate when necessary;
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 regulatory agencies (e.g. NMPA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as GB,YY, IEC, ISO, UL.
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. Learn more by watching this video .
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 .