My client a medical device company in Galway is looking to hire a Senior Regulatory Affairs Specialist for their site on a permanent basis
Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.
- Is an effective regulatory team leader, fully motivated to achieve and demonstrate best practices in line with the goals of the regulatory department.
- Provide regulatory strategies for new product introduction.
- Interface with divisional regulatory colleagues on regulatory matters relating to new product submissions or management of changes to existing devices.
- Assist in the preparation and the management of regulatory and quality system audits.
- Lead in the compiling of regulatory submissions for initial product approval in EU and US markets.
- Liaise with regulatory agencies as appropriate during submission review process.
- Interfaces with manufacturing, engineering, R&D and quality representatives to provide regulatory consultation on the impact of proposed changes to product, processes and the quality system.
- Act as a regulatory team member in product development programmes and demonstrates a good understanding of the PDP process.
- Maintains and enhances cross-functional team relationships.
- Review applicable Corporate SOP’s for effect on local regulatory processes and systems.
- Lead in the Preparation, Review and Update of Technical Files and Design Dossiers.
- Review and approve documentation related to product release.
- Preview device labelling, product and manufacturing changes for compliance and applicable regulations.
- Liase and provide support to regulatory colleagues in the Intercontinental emerging markets.
- Demonstrate and actively promote highest level of professional regulatory discipline.
- Contribute to the regulatory team process.
- Liases with both middle and senior management on any regulatory issues relating to their area.
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.
- Bachelor’s Degree in Engineering, Science or Quality Assurance
- Experience in FDA regulations, ISO 13485 and the Medical Device Directive is required
- A minimum of 5 years’ experience in a similar environment is desirable.
- Excellent communications skills.
- Strong team member with the ability to identify and drive quality improvements.
- Good administrative/organisational ability with attention to detail is required
- Technical writing qualification desirable
For further information on this Senior Regulatory Affairs Specialist II role in Galway please contact Clara Burke on 086 8168273 / firstname.lastname@example.org
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