Here’s what you’ll be doing:
Provide regulatory advice and guidance to R&D, Regions and RA to ensure submissions meet regulatory requirements and maintain up-to-date knowledge of regulatory requirements.
Maintain a working familiarity and practical understanding of the FDA, EU MDD/MDR regulatory requirements as well as applicable requirements from the other international agencies/notified bodies.
Drive the preparation, publication, quality control, and delivery of technical documentation required for compliance with associated submissions and to address questions and issues that arise as part of the registration process.
Support submissions in the company database for ease of access and maintenance.
- Technical knowledge as Practical Engineer, or Advanced Degree in Science or Health Related Field
- Minimum of 3 years of experience in the medical device sector and regulatory experience
- knowledge and familiarity of device regulatory affairs discipline throughout the product lifecycle.
- Excellent organizational and multi-project management skills, with specific attention to detail.
- Working knowledge of international laws, regulations, and guidance that affect assigned devices specifically concerning the FDA, EU Regions, MDSAP, and other WW jurisdictions (Advantages of experience with submissions)
- Working knowledge of QMS requirements (e.g., CE, FDA, MDSAP, etc.)
- proficiency in the Cosmetics regulatory environment and conditions- Advantage
- Knowledge of the quality process, including standards, methods, and procedures.
Come and join us!