Regulatory Affairs Project Manager
- https://a0.amlimg.com/NTM4M2UyNGYwYzQ1NTY5YmE2ZjY2OTJkMzc3Nzc0MjKDbGDA1MWt1blm0DfoEV-TaHR0cDovL21lZGlhLmFkc2ltZy5jb20vOThiYzhjYjZmMGMxYjU2NjBjYWQ5ZjA0MmYxNzEyYTdlOWMwNTcxZDkzMjU1ZjFmMDk4Y2U3ZDkyZWJjNmQzZC5qcGd8fHx8fHwxMzB4MTMwfHx8aHR0cDovL2F2YXRhcnMuYWRzaW1nLmNvbS9kZWZhdWx0LWNvbXBhbnkucG5nfA==.jpg Gemma Hayes Recruitment1 https://www.adverts.ie/jobs/gemma-hayes-recruitment1/ Gemma Hayes Recruitment
- HR Contact:
- Gemma Hayes
- Co. Wexford Wexford
- 15 more ads from this profile
- 2021-02-25 12:09:37 1 month ago
- Ad Views:
|Industry:||Healthcare / Medical|
|Employment Type:||Permanent Full Time|
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.
Tips when applying for a job
- Always add a cover letter
- Check both cover letter and CV for spelling mistakes
- Research the Company and prepare some questions
- Read our applying for a Job online safety guidelines