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Regulatory Affairs Project Manager Regulatory Affairs Project Manager
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Gemma Hayes Recruitment1 Jobs: Regulatory Affairs Project Manager


Industry: Healthcare / Medical
Employment Type: Permanent Full Time
Salary: On Application

Reporting to the Senior Manager Regulatory Affairs, 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. You will be a key member of the RA team. The role requires a high level of ownership and enthusiasm.

Your responsibilities will include:

• 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 for two company sites (Ireland & Germany) in accordance with the company wide UDI / EUDAMED / GUDID initiatives

• Train Regulatory Affairs & Quality System team members on UDI / EUDAMED /GUDID processes and systems

• Assist in the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the Global RA Team

• 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

• Understand and follow company procedures on 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.

The successful candidate will have solid educational background with a Degree in Science or Engineering or relevant scientific discipline, with work experience in Regulatory Affairs and/or Quality Systems, preferably in the Medical Device or Pharmaceutical industry. You will have good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards.

The ideal candidate will have knowledge in CE marking according to MDR; EUDAMED attribute data & UDI requirements and implementation and labelling procedures.

You will have the ability for strong attention to detail in a complex work environment with multiple and competing registration priorities. Good planning and organizational skills.

German knowledge is an advantage.

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