An opportunity has arisen to join a dynamic, independent developer and manufacturer of innovative and technologically advanced products for the global surgical and advanced wound care markets. Our products are sold in more than 70 countries via a network of multinational or regional partners and distributors, as well as via our own direct sales forces in the USA, U.K., Germany, the Czech Republic and Russia.
Provide regulatory affairs execution for the development, regulatory approval and post-approval maintenance of Class I, II(IIa&IIb in EU) and III medical device. The incumbent's responsibilities include tactical and strategic knowledge of FDA medical device regulations, ISO 13485 standards, good hands-on experience in managing 510(k) and PMA to successful approval. This position is reporting to Group QA/RA Director in UK, and can be based from home and hence will require the individual to be proactive in working remotely and is available for travelling when required.
Essential Duties And Responsibilities
• Define and Implement regulatory strategies for new development product and product line extensions in support of the research and development team and provide guidance to ensure that development activities are consistent with overall regulatory strategy
• Work closely with regulatory colleagues to prepare, review and submit domestic and international paper-based and electronic regulatory submissions for new product regulatory approval. These shall include 510(k), PMA, IDE supplements and the management of any amendments
• Work closely with Research and Development, Sales and Operations to provide regulatory project management and oversight (including guidance on protocol development and reporting results) to new and ongoing clinical trials in US
• Support day-to-day regulatory activities to ensure continual regulatory compliance with FDA regulatory requirements
• Review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; appropriately document regulatory disposition of such changes
• Resolve regulatory compliance issues occurring as a result of data discrepancies and manufacturing non-conformances.
• Responsible for managing product recall and medical device reporting and market action in US
Education And/or Experience
• A BS or MS degree in physical or life sciences required. An MBA, in addition to the technical degree, is a plus
• A minimum of 10-12 years regulatory affairs experience in the medical device industry in US, with direct accountabilities related to 510(k)/PMA/IDE submissions and compliance related matters
• Must have direct working knowledge of FDA and hands-on experience in managing new development product in obtaining the approval of 510(k)/PMA/IDE
• Prefer to have knowledge of EU Medical Device Directive and hands-on experience obtaining CE marking
• Must have working knowledge of US Quality System standards
• Experience working across multi-disciplinary levels, functions and regions is required