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Global Regulatory Compliance Manager

1 week ago

Portlaoise, Laois, Ireland Life Science Recruitment Full time
Role Summary:

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for developing and implementing regulatory strategies, managing technical documentation, and providing regulatory support for R&D projects. The ideal candidate will have a strong background in engineering or science, with experience in R&D, QA/RA, and validations. Additionally, excellent technical writing skills, attention to detail, and fluency in English are essential. The role requires strong problem-solving skills, ability to work well under deadlines and pressure, and excellent analytical ability. If you are a motivated and experienced professional looking for a new challenge, please apply now.

Key Responsibilities:

• Develop and implement regulatory strategies to ensure compliance with regulatory requirements
• Manage technical documentation to ensure accuracy and compliance with regulatory requirements
• Conduct global regulatory impact assessments to identify potential risks and opportunities
• Develop and maintain global regulatory procedures to ensure continued compliance
• Provide regulatory support for R&D projects, including 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.