You will be a part of the Regulatory Affairs and Quality Affairs and report to the Director, Regulatory Affairs responsible for an RA team that supports new product development and ensures market access is maintained worldwide with specific focus on EU, US and China.
If you thrive in a fast-paced environment, are used to playing a critical supporting and coordinating role and want to work to build a world-class regulatory affairs team read on.
Provide regulatory guidance through all phases of a project, research and development, pre-clinical and clinical testing, and final data analysis and write specific sections of regulatory submissions.
Provide regulatory and scientific guidance and mentoring of SMEs in different functional areas.
Advice on regulatory strategy and submissions based on the latest regulatory bodies thinking and guidelines (e.g FDA, EU, ICH, etc.)
Assist the project teams in developing and interpreting valid scientific evidence to demonstrate that the device meets the requirements and expectations of regulatory bodies on safety, efficacy, quality and performance.
Requirements:
Bachelor's degree or master's in a scientific field (, engineering, pharmacy, biology, biochemistry, biotechnology, medical technology, or similar).
At least 10 years' combined work experience with Regulatory Affairs and 3 years' experience in a scientific field.
Knowledge and experience in global IVD/MD regulations, quality standards such as ISO 13485, US FDA 21 Part 820, IVDR/MDR, design control, risk management, etc.
Regulatory experience with taking a product from development through regulatory approval in the US and life cycle management, including interactions with regulatory bodies such as FDA and notified bodies.
Good understanding of statistical methods and analysis.
Experience with giving both scientific and regulatory input to claims, test plans, test protocols (non-clinical and clinical).
Detailed knowledge about other technical or SME areas such as software, usability, stability, clinical, post market surveillance.
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