Here at SRG, we are honoured to be working with a thriving, innovative medical device company. Operating on a global scale, they specialise in wound care, trauma, and hemostats, with over 20 products across the business. They are looking for a Regulatory Affairs Associate to join their site based in Crewe.
As the Regulatory Affairs Associate, you will be a member of the team providing regulatory expertise in the research, development, and marketing of products. You will prepare regulatory submissions and ensure regulatory approvals are obtained and maintained within project registration plans and the needs of the business. Some of your main duties and responsibilities will include:
- Provide on-ongoing regulatory advice by participating in project teams throughout product and process development. Following training, be responsible for communication clear advice to ensure that regulatory concerns are planned and accounted for and the relevant data to meet objectives is supplied.
- Support the delivery of the global regulatory programme as required. Compile regulatory dossiers in accordance with national requirement for the approval of products, working to deadlines to ensure despatch within agreed timescales.
- Monitor the progress of dossiers throughout the approval process, identify issues and follow up to ensure that approvals
- To complete the requirements of the global registration plan in line with business unit needs
- To review and approve design change/change control assessments
- To review artwork, labelling and promotional material and advise on its acceptability/compliance with regulations and registered details
- Maintain up-to-date knowledge of regulatory legislation and guidelines.
- Create and maintain Technical Files and documents in line with regulatory requirements.
- Develop and maintain an understanding of the latest global regulatory requirements. Have a working knowledge of individual country legislation
- To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485
As the ideal candidate, you will be educated in a medical, biological, or chemical science discipline and have at least 2 years' experience Medical Device Regulatory Affairs, Post Market Surveillance, Quality Assurance or Design Control or related function. It is advantageous that you have experience in product registrations for global markets such as EU, USA, Australia, Canada, Brazil.
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