Regulatory Affairs Specialist
Our client a leading MNC located in Galway requires an experienced RA Specialist for a permanent job. The RA Specialist will be responsible for supporting regulatory needs of development or on market projects; coordinating and executing global product submissions and registrations, ensuring product safety and labelling compliance.
Key Responsibilities of the RA Specialist
- Be knowledgeable and display a good understanding of regulatory working practices
- Regulatory representative in different company forums within 3 months of start date
- Plan, contribute, evaluate and deliver on the needs of various projects simultaneously where needed
- Actively contribute to continuous improvement opportunities ensuring compliance and best value can be achieved
- Develop technical expertise in the field, specific product (processes) areas and keep abreast with own area of expertise
- Assessment of product risk complexities, product safety and effectiveness
- Coordinates and facilitates submissions making best use of knowledge and expertise across departments and lessons learnt and communicate effectively with key stakeholders
- Educates and shares information and coaches others on regulatory expectations
- Be realistic on capacity; plan and deliver on promises.
- Support cross-training opportunities & skills.
- Analyse working practices and offer flexibility where needed to deliver.
Education, Experience and Skills:
- Level 8 Degree and minimum 5 years working experience.
- Knowledgeable about the requirements of at least one of the following areas, IVD Directive, FDA 510k submissions, cGMP requirements as they impact on RA but support to develop these will be provided.
- An awareness of current development and manufacturing processes, differing product complexities, risk classification and stability are also an advantage.
- Be supportive and self-reliant; be able to act and function independently whilst interacting effectively with others collaboratively
- Ability to work independently and take accountability
For further information on this RA Officer role and other regulatory affair roles please contact Cliona O'Malley on 091 730022/ email@example.com
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