Regulatory Affairs Manager
I'm reaching out as I am currently working with a medical device company in Galway that is going through a very exciting time and looking for a Regulatory Affairs Manager to join them on a permanent basis. You will be working in the research and development facility in Galway and 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.
- Maintain knowledge of current regulatory environment in relevant markets to ensure that information is adequately communicated throughout the company relating to changes in the regulatory environment.
- 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.
What do I need to be a Regulatory Affairs Manager ?
- Minimum 6-8 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.
- Ability to work to manage busy workload encompassing several active projects.
- Excellent oral and written communication skills. Negotiation abilities to identify and resolve issues; highly organised.
- Prioritise own work load and the work load of the project team to achieve project deliverables.
- Quality management system experience.
- Experience of CAPA, Auditing and Risk Management (including FMECA)
If you think the position is the step in the right direction for you and have you have experience in a similar role, don't hesitate in applying.
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