• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations and initiate any relevant regulatory submissions as necessary.
• Supports Sustaining Projects such as design changes, material changes, supplier changes and works as part of core team with other functions to execute these changes.
• Provides guidance to management on upcoming regulatory changes (Brexit, MDR,) and the impact of those changes.
• Responsible for product registration and manage government approval in timely manner
• Establish and maintain close relationship with government agencies to achieve operational effectiveness
• Support marketing department to develop strategic method for product launch in EU and Northern America.
• Prepare regulatory documents and assist sales team on tender and quotation submission
• Support QA, Engineering, Marketing teams in both Ireland and overseas
Field Corrective Action and determine the following action such as government reporting and recall.
• Support the communication of Recall / Field Action activities between manufacturer and distributors in Europe and North America.
• Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports, Post Market Clinical Follow Up (PMCF) plans and reports and clinical evaluations (CEPs, CERs). Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
• Proactively create regulatory training with the HR to internal parties.
• Liaise and provide support to Marketing and the Engineering team in the emerging markets.
• Level 8 Degree in a technical discipline
• A minimum of 5 YEARS Regulatory experience.
• Good understanding of the Regulations in the various jurisdictions. EU, US,
China, Japan, Australia, Canada etc.
• Strong leadership skills, ability to set goals and provide positive and
constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to travel- approximately 10%, including international travel