Regulatory Affairs Officer - Galway

Collins Mcnicholas Recruitment

Galway

Reporting to the Senior QA & RA Manager you 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. You will work closely with other departments providing regulatory support and guidance in a manner that is consistent with the Company’s Core values and engage and facilitate contributions from others. Responsibilities and Duties: Be knowledgeable and display a good understanding of regulatory working practices for IVDs in particular higher risk (e.g. Annex II and PMA products. Take responsibility and positively contribute as 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. Build respect and trust with customers, both internally and externally, to establish effective and influential working relations. Develop high level of personal quality and embrace right first time culture. Be open-minded; recognise and respect differing views from others. 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. Ability to work independently and take accountability. 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. Makes timely and sound decisions after appropriate evaluation of input or information. Educates and shares information and coaches others on regulatory expectations. Be open and contribute towards improvements / changing expectations. Strive for simple and effective solutions. Be supportive and self-reliant; be able to act and function independently whilst interacting effectively with others collaboratively. Be realistic on capacity; plan and deliver on promises. Support cross-training opportunities & skills. Analyse working practices and offer flexibility where needed to deliver. The ideal candidate: The individual will display a strong drive and commitment toward product safety and quality, and meeting customer expectations. The individual will be aware of expectations of them and display autonomy and accountability for their actions. They must be sufficiently open-minded to react to changes in workload as priorities may change. They should display an ability to communicate effectively to their audience both internally and externally including regulatory bodies. The individual should be self-motivated with the ability to deliver appropriate results, having good time management and facilitation skills. The individual should have experience of working practice within regulatory or quality areas. They should be 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. Develop high level of personal quality and right first time culture. Act proactively to overcome regulatory challenges. Be resilient; recognise and deal appropriately where views may differ. Communicate ideas clearly and concisely (oral, written and presentations. Display high level of personal quality and a right first time attitude. Ability to form close working relations to remain informed. Technically competent including higher risk products. Effectively review and analyse the work of others. Sound understanding and awareness of regulations and expectations globally. Awareness of development and manufacturing processes. Communicate in a clear and concise way that is relevant to your audience. Attend meetings and contribute positively. Train and support others as needed ensuring alignment and engagement. Act responsibly, calmly and ethically where views differ to reach agreement. Contribute towards improving work practices to deliver above expected level. Cross reference against regulatory strategic plan. For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.

2563 days ago