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Regulatory Affairs Professional

2 weeks ago

Portlaoise, Laois, Ireland Life Science Recruitment Full time
Job Description
As a Senior Regulatory Affairs Specialist, you will be responsible for developing and implementing regulatory strategies for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and to facilitate the successful launch of new products.

Responsibilities
• Develop and implement regulatory strategies to support product development and commercialization.
• Manage technical documentation, including regulatory submissions, 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.
• Collaborate 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.

Requirements
• Bachelor's degree in Engineering or a related field with 5 years of working experience 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).