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Senior Regulatory Specialist Lead

3 weeks ago

Kilkenny, Kilkenny, Ireland Life Science Recruitment Full time
About this Role

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our client, a leading Medical Device Multinational. The successful candidate will be responsible for developing and implementing regulatory strategies and submissions for complex projects and issues. This role will also involve mentoring and developing staff members to ensure they have the necessary skills and knowledge to perform their roles effectively.

Responsibilities:

• Develop and implement regulatory strategies and submissions for complex projects and issues
• Collaborate with cross-functional teams to ensure regulatory compliance
• Manage global regulatory impact assessments and updates to global regulatory procedures
• Provide regulatory support for R&D projects, input and approval for new product introductions
• Apply technical solutions to problem solving and quality improvement projects
• Use technical writing skills to clearly describe technical information
• Review and assess change control activities for potential impact on current regulatory filings
• Maintain regulatory procedures to ensure continued compliance
• Ensure continual Quality System compliance by adherence to established and evolving internal requirements
• Serve 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
• Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues
• 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
• 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

Requirements:

• Engineering/Science qualification with 5 years of working within R&D/QA/RA in a medical device environment.
• Minimum of 3 years' experience in R&D, QA/RA, Validations
• 3-4 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 in 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
• Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management.