I am currently working with a start up medical device company in Galway that is going through a very exciting time and have an immediate opening for a Regulatory Affairs Manager.If you are looking for a role you can really make your own and be at the beginning of a number of exciting projects this is the role for you.
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 www.realstaffing.com
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