My client a medical device company in Galway is looking to hire a Regulatory Affairs Specialist for their site on a permanent basis
Responsible for Regulatory Affairs support of the product development process, submissions, maintenance of regulatory files and regulatory compliance.
- Working as part of a team responsible for Regulatory Activities and issues occur.
- Reviews change requests to support maintenance of product technical documentation
- Supports sustaining projects and teams on giving direction on regulatory impact on proposed changes. This involves liaison with International countries for impact decisions.
- Assist in preparation and maintenance of Design Dossiers/Technical Files for all products, prepares and submits US regulatory submissions such as 30 Day notices, co-ordinates responses to same in a timely manner.
- Participates in Regulatory Body audits such as FDA & DEKRA.
- Provide input, review and approve facility regulatory activities such as labeling.
- Provide Emerging Markets submissions information to U.S. based and Emerging Markets based International Regulatory Affairs personnel for all products.
- Provide updates on regulatory requirement changes, either on individual product specification or quality systems. Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position.
- Work with the Regulatory group in converting EU MDD files to comply with MDR 2017/745.
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- Minimum qualification required: BSC/BEng degree. Significant relevant experience may be considered in lieu of a primary degree.
- Minimum 3 years’ experience in a similar environment in a technical function
- Regulatory experience preferred but not essential
- Experience in MDD, FDA, ISO, environment
For further information on this Regulatory Affairs Specialist II role in Galway please contact Clara Burke on 086 8168273 / email@example.com
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