Regulatory Affairs Specialist
My client is a highly esteemed Medical Device manufacturer in Galway with sites around the world! There’s a new opportunity for a Regulatory Affairs Specialist to join on an initial one-year contract. In this role, you will work with a well establish team and take responsibility for approving manufacturing, design and process changes and writing that support regulatory assessment. AS the successful candidate, you will have previous regulatory experience gained with Class III devices and have dealt with EU and US regulations.
- Responsible for Regulatory Affairs support of the site, submissions and regulatory compliance.
- Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations and initiate any relevant regulatory submissions as a result of the outcome, if required.
- Co-ordinate the preparation and submission of substantial changes that require review and approval by Notified Bodies.
- Supports Sustaining Projects such as design changes, material changes, supplier changes etc and works as part of a core team with other functions to execute these changes.
- Prepare and submit US Regulatory submissions files such as 30 Day notices, Real time reviews, supplements, amendments, annual reports and 510k’s, and co-ordinate timely responses to FDA questions as required.
- Creation and maintenance of Technical Files and Design Dossiers to allow Products to be CE marked.
- Convert MDD Regulatory files to EU MDR 2017/745 regulations requirements.
- Have a good understanding of the Regulations in the various jurisdictions. EU, US, China, Japan, Australia, Canada etc.
- Maintains and enhances cross-functional team relationships.
- Participate in Regulatory body audits, such as FDA, DEKRA, BSI, HPRA, TGA, Anvisa, and others as they arise.
- Liaise and provide support to regulatory colleagues in the International emerging markets.
- Demonstrate and actively promote highest level of professional regulatory discipline.
- Liaise with both middle and senior management on any regulatory issues relating to their area
- Minimum qualification required: BSC/BEng degree.
- Regulatory experience is essential
- 3+ years of experience in a Regulatory role in the Medical Device Industry.
- Experience in MDD, MDR ,FDA, ISO, environment
- Strong team member with the ability to identify and drive regulatory compliance improvements
- Good administrative/organizational ability with excellent attention to detail.
- Technical writing ability.
For further information on this Regulatory Affairs role please contact Marchon Monroe on 086 044 9473 / talent@HERO.ie
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