Global Regulatory Lead
2 weeks ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible for managing technical documentation, conducting global regulatory impact assessments, and providing regulatory support for R&D projects. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and develop strategic plans to mitigate potential risks.
Key Skills:
• 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.
Benefits:
We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off. Additionally, we provide opportunities for career growth and professional development.
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