Regulatory Affairs Coordinator

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

**Your role**:
Responsible for ensuring the Company's compliance with regulations and laws applicable to the Life Science business of the Company, protecting the company from liability. Additionally, provides expertise on Regulatory and/or Trade Compliance topics.

Provides expert advice to ensure proper evaluation of regulations applicable to products and services provided or under development for the Company LS. Plans and manages Regulatory and Trade Compliance activities on both new and in-line products in accordance with applicable regulations. Stays informed on regulatory trends and publications. Maintains relationships with local authorities and industry associations relevant to the Life Science business of the Company and trains local teams in Regulatory and Trade Compliance topics.

Main responsibilities

Regulatory & Trade Compliance assessments and inquiries:

- Executes regulatory assessment of both new and in-line products to identify applicable requirements from relevant authorities
- Executes investigation and response for regulatory inquiries, as assigned by Supervisor

Product registration:

- Executes regulatory activities to establish and maintain product compliance with requirements from relevant authorities, including product registrations. Responsible for:

- Supporting the development of a submission strategy
- Requesting from headquarters or manufacturing sites, as applicable, all documents and/or dossiers necessary for submission to the responsible authority, in accordance to established internal procedures
- Preparing the files and/or dossiers for submission according to the legal timeframes and within agreed deadlines
- Submitting documents as approved and requested by the supervisor
- Monitoring submissions and keeping supervisor informed about submission date, upcoming questions and final decisions from the authority
- Updating records related to the submission in RIMS as applicable and in accordance to established internal procedures
- Verifying that all product registrations comply with the local legislations applicable and inform supervisor in case of any findings

Site registration
- Executes regulatory activities to establish and maintain site compliance with requirements from relevant authorities. Responsible for:

- Supporting the development of a submission strategy
- Requesting from the sites, as applicable, all documents necessary for submission to the responsible authority, in accordance to established internal procedures
- Preparing the files for submission according to the legal timeframes and within agreed deadlines
- Submitting documents as approved and requested by the supervisor
- Monitoring submissions and keeping supervisor informed about submission date, upcoming questions and final decisions from the authority
- Updating records related to the submission in RIMS as applicable and in accordance to established internal procedures
- Verifying that all site registrations comply with the local legislations applicable and inform supervisor in case of any findings

Product import/export:

- Executes regulatory activities related to compliance with customs requirements from relevant authorities. Responsible for:

- Supporting the development of a submission strategy, if applicable
- Gathering data to prepare statements to the responsible authorities, when necessary
- Preparing documents, collecting signatures and arranging the submission
- Monitoring submissions and keeping supervisor informed about submission date, upcoming questions and final decisions from the authority

Technovigilance:

- Defining procedures to allow the identification of reports that are significant for technovigilance
- Gathering data to prepare reports to the responsible authorities, as necessary
- Preparing documents, collecting signatures/approvals and arranging the submission
- Keeping supervisor informed about submission date and any issues faced
- Archiving reports and other legal documentation or other records in accordance with internal procedures
- Auditing the processes periodically to verify compliance.

Surveillance of new and changed regulations:

- Executes the monitoring of new or changed legislations that impacts the business of the Company Life Science and communicate stakeholders in the organization accordingly
- Keeps records of changes in accordance to established procedures
- Monitors surveillance records to guarantee accuracy and to identify relevant records that should be communicated to supervisor.

Interactions with authorities & Advocacy:

- Interacts with local Governmental officials and Associations and Groups