Senior Regulatory Affairs Specialist
The Sr. Regulatory Affairs Specialist will develop strategies for complex projects and issues related to regulatory processes, compliance activities, documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role.
• Key responsibilities will include (but are not limited to) the following:
• Support global regulatory projects, including, but not limited to, the following areas:
• European regulatory requirements, e.g. EU Medical Device Regulation compliance, design dossier and technical file compliance, application and use of EU harmonized standards etc.
• Development and communication of regulatory strategies for global markets.
• Develop and implement improvements to Regulatory Affairs processes
• Support and lead regulatory compliance activities for Legal Manufacturer transfers
• Apply technical solutions to problem solving
• Apply technical solutions to Regulatory Affairs projects
• Use technical writing skills to clearly describe technical information
• Working with Quality, Operations, Engineering and other internal groups investigate and recommend solutions to address potential regulatory issues
• Lead departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks
• Review and assess of change control activities for potential impact on current regulatory filings.
• Maintenance of Regulatory procedures to ensure continued compliance.
• Ensure continual Quality System compliance by adherence to established and evolving internal requirements.
• Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management and product labeling as they relate to registration and commercialization of medical devices.
• Support Regulatory inspections at the site as directed.
• Liaise with other departments to ensure correct supporting data generated and provided in a timely manner.
• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives
Essential skills / experience
• Engineering/Science qualification with 4/5 years of working within R&D/QA/RA in a medical device environment.
• 4/5 years experience in R&D, QA/RA, Validations – essential
• 4/5 years experience in Risk, Clinical and Biocompatibility – an advantage
• Excellent technical writing experience within a medical device environment - essential
• Attention to detail and accuracy – essential
• Fluent English, both written and oral - essential
• Ability to work well under deadlines and pressure
• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);
• Excellent analytical ability
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
• Travel up to 20%
• Approachable and enthusiastic .Flexible and adaptable.
• Travel to Europe and Malaysia
• Able to work on own initiative and as a team player.
• Good organizational skills with cultural awareness and sensitivity
• Good judgment and problem solving ability & is capable of understanding the impact of decision making on both the company and their customers.
Clodagh Nerney | Tel: +353 (0) 1 507 9254