Regulatory Affairs Manager

CPL

GALWAY

Summary. Taking an active role in developing regulatory strategies for new products. Management of regulatory submissions to regulatory authorities for the companys 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. Job description. 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. Compile/review regulatory documentation. Manage regulatory projects. Support the preparation of clinical reports. 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. Provide a regulatory interface to the companys clinical and commercial operations. Develop and advise on regulatory strategies. 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. Education & Experience. Bachelors or Masters degree in science, pharmacy, engineering or life-sciences related field. Minimum 8 years experience in regulatory affairs. Previous experience in drug/device combination product filings highly desirable. Understanding of regulatory strategy and determination of documentation requirements, timelines, budgets and filing options. 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 more information regarding this role contact Brenda Flannery on 091 507 521 or email Brenda.flannery@cpl.ie. Visit www.cpljobs.ie for more of our open roles.

1618 days ago