Head of Regulatory Affairs
Yesterday
🔄 Hybrid – Cambridge
Description
• Manage regulatory compliance of TidalSense’s medical device products throughout the full product lifecycle. • Ongoing regulatory compliance of TidalSense’s medical device products (both hardware and software). • To support the management team in understanding the regulatory framework in which the business is expected to operate and provide strategic advice on the regulatory approach to be taken. • Provide regulatory input to technology & product development strategy. • Monitor regulations, applicable standards, guidance documentation, and state of the art as they apply to TidalSense’s medical device products, and plan responses to changes. • Liaise with global regulatory authorities and delegated bodies in initial certification and re-validation/certification of medical devices and the quality management system (QMS). • Maintaining medical device databases as required by regulation. • Provide guidance to staff involved in the maintenance of the QMS to ensure that is effective and meets the regulatory requirements. • Actively support preparation and organisation of technical files for initial certification and re-validation, and provide hands-on support, training and guidance to staff involved in the generation and maintenance of technical files. • Write and maintain any regulatory checklists required by regulations. • Coordinate and deliver post market activities including surveillance, vigilance, customer feedback and any related corrective and preventive action. • Help to deliver training on the QMS and regulatory compliance to existing and new staff. • Manage relationships with consultancies and other organisations that provide guidance or services related to ongoing regulatory compliance.
Requirements
• Ability to understand scientific and technical risks associated with biocompatibility, software, machine learning, cybersecurity and electrical safety of medical devices. • Ability to analyse and understand data to make and communicate decisions based on objective data. • Resilience and flexibility to work in a busy and changing / dynamic environment with ability to deal with workload peaks and troughs. • Ability to organize and prioritize work in the context of achieving team goals. • Ability to work as part of a team. • Bachelors degree (or equivalent) in a science or engineering discipline. • Had responsibility for US FDA medical device approval, including preparation of pre-submission documentation, break-through applications, meetings with FDA, and/or US regulatory filings. • At least 5 years’ experience in regulatory and quality aspects of medical devices • At least 5 years’ experience in leading class IIa or above certification of PEMS and software medical devices under EU MDD/MDR or FDA, including building and maintaining technical files and post-market surveillance. • At least 3 years’ experience as person managing either a ISO 13485 or 21 CFR 820 QMS.
Benefits
• Flexible working hours to support your work preferences • Hybrid working as per requirements above • Beautiful award-winning Cambridge UK office stocked with quality drinks & snacks • Work from abroad for 1 week per year • Buy / sell up to 5 days annual leave • Generous individual personal development budget + dedicated development days • Mental Health support: wellbeing support and free 24/7 access to qualified counsellors and advisors • Wellness budget • Coaching and mentoring - in partnership with Horizon37 who provide team coaching and mentoring. • Team events and celebrations • 25 days annual leave + 8 public holidays • Pension: TidalSense contributes 5% of qualified earnings (actively looking to increase this) • Annual performance-based bonus • Discretionary share options scheme
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