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In this role, you have the opportunity to

This position is responsible for supporting Q&R tasks and participate in key Q&R projects locally with primary focus on product registration/renewal/re-registration, quality support as well as providing department administrative support where needed.

You are responsible for

• Performs the coordination and preparation of document packages (CSDT) for the pre-market regulatory submissions locally and if required, regionally.

• Prepares and submits Field Corrective Action reports and adverse event reports to the local competent authority, if required, including any additional communications to local competent authority.

• Good Communication skills, including maintaining good working relationships with local competent authorities from various different departments or agencies.

• Reviews and obtain approval from line manager on local labeling, assist with the right processes to take place locally.

• Provides supports for local tasks including preparation of first time registration, renewal and re-registration.

• Support and maintain the local/regional Quality Management System(s) (policies, procedures, work instructions), with revisions and implementations of new regional policies and processes.

• Assist and participate in local/regional internal audits as well as observing and assisting in the preparation for L1 & L2 audits

• Assist and drive CAPA process locally.

• Maintain ASEAN Quality Management System (policies, procedures, work instructions)

• Assist quality initiative projects with investigation and data collection.

• Assist in driving the completion of Training Management System locally.

• Review and process customer feedback and complaints between market and BU.

• Assists the in administrative duties related Q&R (i.e. maintenance of registration database, document control, update of licenses on network drive/share point site, webs based application etc.).

• Assist project assign by line manager.

Basic Qualifications:

• Bachelors Degree with at least 5 years of experience strongly in Regulatory Affairs (especially for Medical Devices)

• Proficiency in the use of Microsoft Access and Excel is an advantage.

• Strong interpersonal skills in the areas of verbal and written communication, telephone courtesy and professionalism.

• Strong organizational skills and take initiative.

• Attention to detail and the ability to maintain confidentiality of product registration documents.

• Ability to prioritize and handle several projects concurrently.

• Must be self-motivated and have ability to take ownership of her/his responsibilities.

• Must be a team player and capable of working with minimal supervision.

• Must be able to set goals and accomplish them within set time schedule and budget.

• Must have good command of the English language.

• Ability to solve practical problems and deal with a variety of situations where limited direction has been given. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

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 .