Head of Regulatory Affairs

at  TidalSense

OVERVIEW

TidalSense is a respiratory technology company with a mission to transform the diagnosis, monitoring and management of chronic respiratory conditions, such as asthma and COPD. The company has ambitions to enable a population-scale change in respiratory care through global deployment of its technologies. TidalSense is about to launch the first-of-its-kind AI-driven (software medical device) diagnostic test for COPD which uses the company’s unique, patented, sensor technology embedded in the N-Tidal device.
We are seeking a Head of Regulatory Affairs to support compliance of the company’s existing medical device portfolio as well as to lead the company’s regulatory affairs strategy for the US and other global markets. We are at an exciting phase in our journey as we transition from a start-up to a scale-up. You will be joining a passionate, socially-motivated and multi-disciplinary team covering engineers, scientists, clinicians, designers, product and usability specialists. This is a unique opportunity for a driven and autonomous individual to work in a leadership capacity, to drive regulatory market access strategies to deliver impact in the real world and change people’s lives. We are seeking someone who is comfortable working in a fast-paced, agile, and diverse team environment, and who is also committed to our mission to revolutionise respiratory medicine.

SKILLS & COMPETENCIES

Essential

• 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.

QUALIFICATIONS & EXPERIENCE

Essential

• 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.

Desirable

• IRCA-certified or equivalent ISO 13485 lead auditor
• Experience of achieving compliance against IEC 60601-1 series
• Experience of achieving compliance against ISO 10993 series
• Experience of achieving compliance with ISO 62304
• Experience with quality or regulatory aspects of respiratory medical device development
• Experience of applying FDA cybersecurity requirements
• Experience of the application of machine learning as it relates to regulatory compliance in the EU and USA.

OTHER REQUIREMENTS

• Legally eligible to work in the UK without a visa or sponsorship
• Will need to be able to work in person in the Cambridge office at least 2 days / week (ideally more).

JOB PURPOSE

To manage regulatory compliance of TidalSense’s medical device products throughout the full product lifecycle.

KEY DUTIES & RESPONSIBILITIES

• 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.