We are seeking to recruit a QA/RA Manager with significant IVD medical device experience, to join our team. You will be responsible for managing and maintaining our ISO 13485 quality management system to ensure we have a sustainable and compliant QMS that fully supports the current and future commercial needs of the business. Specifically, you will assume authority for our IVD product supply chain, maintaining quality assurance and compliance and taking responsibility for the overall quality of products released by the company.
Further you will oversee the company’s regulatory strategy, providing sound advice to executive management throughout the product development/product enhancement lifecycle, to ensure that regulatory requirements are being met and to support timely product certifications/authorisations.
The key responsibilities of the role are:
• To oversee and continually review our quality management system, ensuring that improvements are identified/actioned and that deficiencies are addressed at their root cause.
• Developing regulatory strategies in accordance with market and business objectives and act as advisor on regulatory aspects of product development and change (working with external advisors, as required)
• Maintain oversight in ensuring that product Technical Files/Design History Files/Design Dossiers comply with regulatory requirements and are kept up to date, in response to changing regulations
• Maintain oversight of product labelling activities and provide guidance to ensure claims meet internal and external standards
• Keep up to date with impending changes and developments in regulatory legislation and compliance requirements as well as evolving best practices in QA and regulatory compliance
• Liaise with the company’s notified body/authorised representative and oversee submission processes across multiple territories.
• Act as Person Responsible for Regulatory Compliance (PRRC) with respect to our IVDR responsibilities and act as Management Representative for our ISO 13485 Quality Management System
• Maintain oversight of Risk Management activities
• Lead internal & external audits
This position requires:
• BSc life sciences degree or equivalent industrial experience
• At least 3 years’ experience in a QA/RA role in the IVD Medical Device industry
• Practical knowledge of ISO 13485, FDA QSR, 21CFR820, ISO 14971, IVD Regulation 2017/746/EU, IVD 98/79/EC
• Experience of working/engaging with Notified bodies & and regulators (e.g. FDA, CMS)
• Experience of preparing high-quality regulatory dossiers/design files
• Experience conducting internal and external audits
In addition, the following experiences & skills are desirable:
• Knowledge of software quality assurance (e.g. EN 62304)
• Experience of using EU Regulatory registration systems
• Direct engagement/management of clients and/or suppliers
Successful candidates will also possess an ability to recognise, analyse and problem solve complex issues in a methodical manner. You will be well organised and able to work independently and within a team setting.
You will have excellent verbal and written communication skills, including attention to detail and strong questioning & listening skills.