Head of Quality and Regulatory Affairs
2 months ago
As Head of Quality and Regulatory Affairs you will manage the Quality, Regulatory and Clinical Teams for an exciting Medical Device Manufacturer working on Class III Devices. Giving overall guidance and leadership to QA/RA functions including product registration, complaint handling and reporting, internal/external auditing of the quality systems and supporting R&D and Marketing.
Pivotal in developing company policies, procedures, and training to ensure efficient and effective operation of the companies quality system and regulatory requirements. Serving as the Quality System Management Representative and Medical Device Person Responsible for Regulatory Affairs.
Responsibilities:
To oversee and continually review the quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause and appropriate procedures are developed and fully implemented. To ensure a sustainable compliant quality management system that fully supports the current and future commercial needs of the business.
Ensuring complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with the company QMS.
Ensure effective data management systems, policies, processes and programmes to provide assurances of ongoing statutory and regulatory compliance and delivery within budgets whilst providing for a high level of internal and external customer satisfaction.
Remain up to date with impending changes and developments regarding regulatory and compliance requirements as well as evolving best practices in compliance control.
Develop, manage and maintain the company’s device family technical files and product specific design dossiers ensuring compliance with the relevant regulations.
Develop and maintain an excellent understanding of the company’s procedures and products.
Keep up to date with changes in regulatory legislation and guidelines together with customer practices and changes to device standards and testing (globally)
Provide sound advice to management throughout the development of new product and product enhancement submissions, to ensure that the principles of the submission accurately reflect the regulatory requirements to aid timely product introductions and certificate renewal processes.
Liaise with the company’s notified body / competent authority, & oversee international submission processes
Collaborate with the Regulatory Affairs personnel from distributors and partners, providing assistance for the maintenance of international product registrations.
Ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organisation
To be the Person Responsible for Regulatory Compliance (PRRC) as defined in Article 15 of the MDR 2017/745.
Skills/Experience:
Degree educated, or equivalent, in a life science or engineering discipline
At least five years’ experience in medical device regulatory environment.
An in-depth knowledge, and appreciation, of the regulatory requirements for placing class III medical devices on the European market. Experience of North America, South America, Asia-Pacific markets would be desirable.
Strong leadership and influencing skills
Experience building a high performing team, managing the performance of team members with varying levels of skill and experience, and providing support and mentorship.
Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed time scales.
Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.For immediate consideration please forward your most up to date CV
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
Check us out on our
or contact (url removed) Austin Fraser International Ltd is registered in England: (phone number removed) Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU
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