Regulatory Affairs Data Specialist

Job Description

o The Regulatory Affairs Data Specialist works mostly with our RIM(regulatory Information Management) tools in respect to Standards and a number of regulations. This can be a person who is looking to get a better understanding how Standards Regulatory works in the international market incl EU. This role will allow you to see multiple business within Philips.

You are responsible for

• Work according the business applicable processes and as ambassador of the Philips values.

• Maintain and update regulatory databases and information repositories using RIM tools.

• Ensure the accuracy, completeness, and consistency of regulatory data.

• Utilize and manage Regulatory Information Management (RIM) tools effectively to track and manage regulatory data.

• Provide training and support to team members on the use of RIM tools.

• Identify opportunities for process improvements within the regulatory affairs data management function.

• Collaborate with cross-functional teams, including regulatory affairs, quality assurance, and other relevant departments.

You are a part of

You will be a team member of the global Philips regulatory organization and will work within multiple Philips business to support the role out and optimalisation of the recently introduced RIM system.

To succeed in this role, you should have the following skills and experience.

o Bachelor’s degree in a technical/quality/law/pharma discipline

o 2-4 years of experience in the medical device industry

o Goal oriented, reliable, and extremely well organized with strong attention to detail.

o Demonstrates ability to work independently and work through projects with minimal supervision.

o Affinity with medical device regulations (21CFR), FDA Law, MDD, other global laws and regulations is a plus.

o Familiarity with preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide is a plus.