Description:
As this company continues to see success and invest in new product development, it is time to grow the Regulatory Affairs team and they are looking for a passionate leader like you! If you want to work in a business that recognises the importance of Regulatory Affairs, is passionate about what they do and is sitting at the forefront of innovation in software and AI, this is the place for you. You will have the opportunity to be responsible for the Regulatory strategy for the US and oversee the full product lifecycle from concept to market. Supporting you with these activities will be your team of RA experts reporting directly to you.
AsTeam Leader Regulatory Affairs you will (not an exhaustive list):
- Identify the applicable regulations and guidelines for US compliance and registration and advise other teams accordingly
- Manage your portfolio of products through the US registration/renewal process (for new and existing products)
- Strategic planning of RA activities and programs
- Compile technical documentation and prepare the regulatory documentation for submission to EU and US market (with support from external consultants where needed)
- Be responsible for technical documentation review, and support the creation and continuous improvement of regulatory related processes
- Monitor and analyse medical device regulations to ensure submission requirements and design output compliance
- Lead a team of regulatory experts and support their continuous development
- Closely collaborate in multi-disciplinary teams from Regulatory, Quality, Technical, Marketing & R&D on new product development projects and advise on US requirements to ensure compliance
- Support key relationships with regulatory authorities and consultants
- Develop, implement and maintain internal procedures ensuring ongoing compliance with the relevant regulations, legislations, standards and guidance
- Support audits conducted by Notified Body/Conformity Assessment Bodies and Regulatory Authorities
Your qualifications:
- Minimum 5 years of regulatory affairs experience with medical devices
- Experience with 510(k) applications with no predicate