RA Project Manager
Our expanding Life Sciences Client in Wexford, the ''Sunny South East'' of Ireland, have a requirement for an RA Project Manager to join their expanding teams. Exciting opportunity with excellent career development opportunities with this world-renowned Medical Device organization
What is in it for you?
- This is great opportunity to expand your skillset and grow your career in this fast moving, dynamic and agile business.
- Attractive salary and benefits package on offer together with a friendly, welcoming and collaborative working environment
- Remote Working available
- Onsite parking and canteen (remote working initially)
- Days role, flexitime available & half day on a Friday!
- Commutable distance from Kilkenny, Waterford, Tipperary or Wicklow.
Reporting to the Senior Manager Regulatory Affairs, you will be a key member of the RA team. You will be responsible and accountable for regulatory support, with a primary focus on UDI, for operations, product development and quality to ensure that the product is in compliance with all internal and external regulatory requirements.
- Regulatory Affairs Subject Matter Expert on UDI / EUDAMED / GUDID requirements globally (e.g. MDR UDI, US UDI, China UDI, EUDAMED, GUDID, etc.)
- Implement and maintain global UDI /EUDAMED / GUDID requirements and associated procedures in accordance with the company wide UDI / EUDAMED / GUDID initiatives
- Assist in the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the Global RA Team
- Train Regulatory Affairs & Quality System team members on UDI / EUDAMED /GUDID processes and systems
- Reviews Engineering Change Orders, Design Change Notices and other deviations to assess impact to UDI
- Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements
- Provide positive example and actively promote compliance to all standards
- Maintain a professional working relationship with internal and external customer and support staff;
- Prepare and present project updates and technical discussions.
- Degree in Science or Engineering or relevant scientific discipline with experience in Regulatory Affairs and/or Quality Systems, preferably in the Medical Device or Pharmaceutical industry.
- Proven Project Management experience
- Good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards.
- Knowledge in CE marking according to MDR; EUDAMED attribute data & UDI requirements and implementation and labelling procedures.
- Strong attention to detail and the ability to work effectively in a complex work environment with multiple and competing registration priorities.
- Good planning and organizational skills.
- High level of ownership and enthusiasm.
- German knowledge is an advantage.