Description:
As a newly introduced role, the UDI and Labelling compliance Engineer will become the subject matter expert in unique device identification and label design to support Aerogen's strategic growth plans. You will be responsible for leading the implementation of global UDI initiatives, supporting product registration and re-registrations in geographical regions, and addressing necessary changes to meet regional regulatory and OEM customer requirements. Close collaboration with cross-functional teams including Commercial, Regulatory, Supply Chain, and external consultants will be vital to successfully carry out your responsibilities. By making significant contributions in this role, you will directly contribute to Aerogen's expansion efforts and assist in achieving regulatory compliance objectives.
What are the key responsibilities?
- Act as Aerogens subject matter expert (SME) on the interpretation and implementation of international regulatory standards including and not limited to ISO 15223-1, ISO 20417, FDA 21 CFR Part 801, EU MDR 2017/745 and GS1.
- Participate across a diverse range of project teams as SME to support all label and UDI decision-making.
- Lead and oversee projects for the implementation of global Unique Device Identification (UDI) in compliance with regional requirements and medical device regulations.
- Coordinate the gathering and loading of UDI data into various UDI Databases, including GUDID and EUDAMED.
- Manage internal records pertaining to UDI information.
- Design product labels that adhere to regional requirements and medical device regulations.
- Review and verify internally printed artworks and externally sourced labels and documentation to ensure compliance with UDI requirements according to EU MDR regulations, FDA guidelines, GS1 Standards, and Aerogen Standard Operating Procedures (SOPs).
- Review Customer Agreements concerning UDI data and labeling responsibilities.
- Create and update work instructions and procedures governing UDI and labeling processes.
- Collaborate with suppliers and generate purchase orders for outsourced labeling and translation services.
- Generate product Bills of Materials and Packaging Configuration Instructions.
- As SME present relevant information and defend decision making in regulatory audits.
- As SME and working with the Regulatory function stay up to date with all labelling and UDI international standards, participate on standards working groups and maintain Aerogens governing documents in line with standards.