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Regulatory Affairs Manager
You will be working in the research and development facility in Galway, You will be working closely with the Director of Regulatory Affairs.
What will I be doing as a Regulatory Affairs Manager?
* Manage the preparation of global regulatory submissions including but not limited to PMA/CE Mark/IDE submissions, IDE/PMA supplements and amendments, EU Technical File submissions, EU Substantial Change Notifications, EU Clinical Evaluation Reports, Post Market Surveillance Reports and Annual Reports.
* Manage the review process for regulatory submissions ensuring effective communication with the reviewers and within the company to ensure that queries are addressed in a timely and effective manner.
* Compile/review regulatory documentation to support global pre and post market clinical study submissions.
* Manage regulatory projects to ensure company milestones are achieved.
* Support the preparation of clinical reports from IDE, OUS and Post Approval clinical studies.
* Review and approve product labelling changes, promotional literature and marketing materials prepared by the Company and its distributors.
* Provide input to regulatory aspects of design control, change control, non-conforming process.
* Participate as a Clinical Project team member to provide regulatory oversight of clinical operations including provision of safety reporting and vigilance support.
* Provide a regulatory interface to the company’s clinical and commercial operations.
* Develop and advise on regulatory strategies for existing and changing products in collaboration with R&D, Manufacturing and Quality Assurance departments, as appropriate.
* Responsibility for assisting in implementing regulatory requirements in accordance with US Regulations, ISO 13485, MDD 93/42/EEC, MDR 2017/745 and other jurisdictions as required.
* Assist with training of company employees in relevant areas of regulatory affairs.
* Provide regulatory oversight of customer complaint handling procedure.
* Manage assigned aspects of the Quality System, as required.
What I need to be a Regulatory Affairs Manager?
* Minimum 6 years’ experience in regulatory affairs, ideally with Class III cardiovascular medical devices.
* Previous experience in drug/device combination product filings highly desirable.
* Understanding of regulatory strategy and determination of documentation requirements, timelines, budgets and filing options.
* Proficient in all Microsoft Office applications.
* Quality management system experience.
* Experience of CAPA, Auditing and Risk Management (including FMECA).
Don't miss out on your chance to join a great company.To apply please send an up to date CV
To find out more about Real please visit (url removed)
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
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