Senior Regulatory Affairs Specialist: Key Role in Driving Regulatory Strategies
The Senior Regulatory Affairs Specialist will play a pivotal role in shaping the regulatory landscape for our company's products. Reporting directly to our regulatory management team, this individual will be responsible for developing and implementing comprehensive regulatory strategies that ensure timely and successful registration, approval, and maintenance of our products.
This key position involves collaborating closely with cross-functional teams, including development project teams, engineering, marketing, operations, quality, and clinical affairs, to guarantee compliance with applicable regulations and standards. The goal is to facilitate product commercialization and market access while maintaining the highest standards of regulatory excellence.
Key Responsibilities:
* Lead research, analysis, and communication of information pertinent to the appropriate regulatory pathway for new or modified products.
* Drive FDA submissions and Technical File development for medical devices, ensuring alignment with regulatory strategy and global compliance requirements.
* Respond to requests from notified bodies, competent authorities, and/or distributors to prepare and submit documentation for marketing approval, as well as provide routine regulatory information.
* Provide regulatory direction to development project teams as a core team member.
* Advise other functional units on the requirements in each target market.
* Review proposed labelling/instructions for use for compliance with applicable local and international regulations.
* Recommend changes for labelling and internal documentation, reports for regulatory compliance.
* Coordinate multiple projects simultaneously and provide regular reports to regulatory management, clinical affairs, and others as required.
* Support regulatory compliance activities, including manufacturing site registration and GMP audits as needed.
Requirements:
* Level 8 Degree in Science or Engineering
* Minimum 3 years experience in Regulatory Compliance
* Experience in the Medical Devices industry is required
* Understanding of applicable guidelines and regulations, for example experience with ISO 10993
* Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745, and international regulatory agency requirements
* Ability to effectively manage multiple projects and priorities
* Excellent attention to detail and results-oriented