Head of Regulatory Affairs - Bristol, United Kingdom - Neuronostics Ltd

Description

This is an exciting opportunity to provide regulatory leadership to Neuronostics at a time of significant growth and international expansion.

Reporting to the Managing Director, you will lead and be accountable for the regulatory and compliance activity of the company.

You will ensure the identification and satisfaction of relevant standards required for enabling market access for company products across its major market territories.

As the Head of Regulatory Affairs, you will have a deep understanding of the quality standards which must be met for our key market access (UK/EU/US) to be achieved and maintained.

As we are developing Software as a Medical Device (SaMD) healthcare products, you will need to be aware of the working practices/tools used when developing software and be comfortable working closely with technical staff.

You will also thrive working in a start-up environment, happy to learn on the job, adapt your approach as new opportunities emerge and lead from the front as required in a small, but rapidly growing team.

• Play a key role in developing company strategy as a member of the Neuronostics leadership team;
• Act as an ambassador for Neuronostics, ensuring Neuronostics is part of the conversation both regionally and nationally on topics of regulation and compliance;
• Lead company relationships with regulatory consultants and other 3rd party suppliers as appropriate;
• Be responsible for all company regulatory requirements;
• Lead the company regulatory strategy ensuring its alignment to product roadmap;
• Maintain our QMS processes, report on QMS performance, promote regulatory requirements and support top management;
• Liaise with external bodies such as EU Notified Bodies (NB) or UK Approved Bodies (UKAB) as the named individual;
• Develop and manage policies and procedures which are a requirement for regulatory compliance;
• Conduct research and analysis of regulatory requirements and policies for markets (usually the US, the UK, Canada and Germany) that the company is looking to enter with existing and future products;
• Ensure the company systems and products meet the relevant quality and regulatory standards, monitoring regulatory developments and changes to ensure continued conformity with evolving requirements;
• Working with the Chief Technology Officer, ensure the accurate and timely creation of technical and information governance documentation required to maintain product market access;
• Working with the Clinical Safety Officer, ensure risk assessments are performed to required standards;
• Working with the Product Team, ensure that Neuronostics' products are developed with a complete understanding of the regulatory landscape in which they will ultimately be deployed;
• Working with the Head of Clinical Operations to take the lead on data management for the clinical studies, specifically EDC setup and management to be compliant with EU Clinical Trials, FDA and GCP regulations;
• Lead ISO certificate audits especially ISO 13485 Audits Identify and report on quality KPIs to the board.

• First degree in a relevant field;
• Experience regulating MedTech products, ideally Software As a Medical Device and/or AI powered solutions;
• Experience with securing approvals and successful external audits from bodies including FDA / EU MDR / UK MHRA / CE Mark / UK CA / CDMR / ISO 13485 / ISO10993;
• Developing and maintaining a Quality Management System (QMS);
• Meeting NHS standards in clinical risk management
• DCB0129/0160;
• Keen eye for detail and exceptional presentation skills;
• Trained to ISO 13485 internal auditor standard.

• Defining regulatory strategy for company products and conducting research to understand the regulatory landscape in target markets;
• Patient focused products and end user medical devices;
• Qualified to act as Person Responsible for Regulatory Compliance (PRRC) per Article 15 of the EU Medical Device Regulation (MDR);
• Certified ISO 13485 Lead Auditor.

• A competitive salary of up to £60K reflecting your level of experience and success;
• Company Pension Scheme (you contribute 2% and the company 7% on qualifying earnings);
• A dynamic and collaborative environment, where curiosity and innovation are encouraged and rewarded;
• A diverse and highly experienced team combining scientific, technical and commercial expertise;
• Key leadership role with the opportunity to actively shape the development of Neuronostics;
• 25 days annual leave, plus public/bank holidays. Staff members also receive an additional day off to celebrate their birthday;
• Access to ongoing professional development;
• Regular staff events and company away days.