Responsible for the management of the company’s regulatory affairs activities including but not limited to:
- Taking an active role in developing regulatory strategies for new products.
- Management of regulatory submissions to regulatory authorities for the company’s products.
- Ensuring assigned regulatory activities associated with clinical studies are fulfilled.
- Management of routine regulatory activities including clinical evaluation, safety and vigilance reporting and post market surveillance reporting.
- Maintenance of existing global regulatory approvals.
- Supervision of direct regulatory team members to ensure timely and successful achievement of regulatory goals.
- 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.
- Manage assigned aspects of the Quality System, as required.
- Manage regulatory resources to ensure timely and successful achievement of regulatory goals.
- Minimum 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.
- Willingness and availability to travel on company business.
- Proficient in all Microsoft Office applications.
- Experience of working with the following standards: ISO 13485; ISO 14155; 21 CFR 820;
21 CFR 814; 21 CFR Parts 50, 54, 56, 812; MDD; EU MDR; ICH GCP.
- Quality management system experience.
- Experience of CAPA, Auditing and Risk Management (including FMECA).
For a confidential discussion and more information on the role, please contact Stephen Kelly on 091-706714.