Director of Quality and Regulatory Affairs (ISO13485, FDA, MDR)

SJB Technical Recruitment Ltd
10 Aug 2018
15 Aug 2018
Contract Type
Full Time
Director of Quality and Regulatory Affairs (ISO13485, FDA, MDR)


£Neg + benefits

This is a fantastic opportunity to join a fast growing, innovative, high technology medical devices company, developing an advanced system for use both in the home and in medical centres that will significantly improve the quality of life of the patients involved. The product is unique and set to make a significant impact on a multi-billion dollar global market.

They now require a Director level appointment of Chief of Quality & Regulatory Affairs (QARA) responsible for developing, implementing and maintaining a Quality and Regulatory strategy and for ensuring Regulatory Compliance in the company’s chosen markets and all other future expansion markets.

This role will lead all activities required to secure, maintain and adhere to the necessary regulatory approvals, including budget responsibility and the management of an internal team and external advisors, while working closely with key internal and external stakeholders, be Management Representative with respect to ISO13485 and act as the company’s primary representative and point of contact with all external regulatory agencies.



·Provide overall leadership and direction of the QARA team within the organisation whilst ensuring co-ordination and cohesion with other internal functions

·Build, develop and motivate a high performing team, establishing the optimal structure, developing capabilities and creating an environment that encourages ‘world-class’ behaviour

·As a member of the senior management team, develop the overall business plan and financial forecast to meet business objectives

Regulatory & Risk Management

·Lead the process to ensure preparation and submission of a successful FDA submission in order to obtain (and ultimately maintain) regulatory clearance for the company product and accessories in the USA

·Manage all activities required to ensure ongoing compliance with FDA and MDR regulations, including all appropriate international standards such as ISO13485

·Ensure input into product design & development such that products are designed in compliance with regulatory requirements and applicable standards

·Oversee Risk Management process to ensure that suitable solutions are found whilst not compromising patient safety

·Establish an appropriate Post Market surveillance process that manages all the required inputs to ensure that it is an effective process and fully supports design & development activities. This should also include the Clinical Evaluation summary

·Manage a Post Market Vigilance reporting system to meet all Regulatory requirements

·Define and implement strategy for future regulatory submissions with respect to label expansions and/or product improvements

·Ensure maintenance and accuracy of all current technical documentation supporting regulatory compliance and the Technical File

Quality and Audit Management

·Identify and evaluate new systems, trends and general best practice within Medical Device quality assurance and compliance to ensure processes and tools (particularly the QMS) used in the company are optimal at all times whilst meeting current business needs

·Oversee and maintain the department strategy relating to various audits including scheduling, planning and preparation and collaborating with the business on audit compliance

·Provide leadership and counsel to the company on audit compliance issues and suggested resolution as and when they arise

·Identify and manage external advisors and consultants, as necessary

·Build and maintain effective working relationships with key internal and external stakeholders and regulatory bodies


·Degree qualified in a relevant discipline

·Significant relevant experience, including previous track-record managing and securing Regulatory approvals for complex Class II medical devices

·Familiarity with the requirements of Code of Federal Regulations Title 21 (21 CFR 820); Quality Systems Regulations, ISO13485 and other applicable standards

·Experience in regulatory submissions and resubmissions to a range of other relevant jurisdictions

·Able to evidence responsibility for maintenance of technical documentation

·Able to demonstrate extensive knowledge of risk, clinical evaluation/trials and vigilance.

·Able to provide evidence of understanding and familiarity with Programmable Electrical Medical Systems (PEMS) and high integrity environments requiring multidisciplinary development across mechanical engineering, software, electronics, system integration, etc.

·Strong organisational and leadership skills, with proven experience in aligning a multi-disciplinary team behind both a long-term strategy and near-term plans

·Ability to lead and manage employee and department performance, creating a culture of highly motivated and high performing individuals leveraging strong interpersonal and intercultural skills

·Flexible for occasional UK and International travel to meet with Regulatory Bodies, 3rd party suppliers and other key stakeholders

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