Quality Manager

at  St Andrews Innovation Limited

EDUCATION AND QUALIFICATIONS

· A bachelor’s degree (or higher) in a relevant field such as Biomedical Engineering, Regulatory Affairs, Life Sciences, or a related discipline.
· Advanced certifications or training in quality management systems or regulatory standards/affairs are highly desirable.

EXPERIENCE

· Proven experience in the medical device industry, particularly in roles focused on quality management and regulatory standards
· Demonstrated expertise working with Quality Management Systems (QMS).
· Hands-on experience with international regulatory standards
· Familiarity with risk management processes and post-market surveillance requirements.

KNOWLEDGE AND SKILLS

· In-depth knowledge of medical device standards and regulations
· Strong understanding of regulatory pathways in multiple markets (e.g., UK, EU, USA, and other international territories).
· Proficiency in tools and software for document control, audit management, and process improvement.
· Excellent problem-solving skills with the ability to identify and mitigate risks effectively.
· Strong project management and organisational skills, with the ability to manage multiple tasks and deadlines.
· Exceptional written and verbal communication skills for interaction with regulatory bodies, consultants, and cross-functional teams.

KEY RESPONSIBILITIES

1. Leading on management and implementation of our subsidiary St Andrews Medical Innovation’s (SMI’s) quality management system (QMS)
2. Ensuring new products progress through the relevant regulatory pathways in the UK, EU, USA and internationally

DUTIES AND TASKS TO FULFIL THE KEY RESPONSIBILITIES

1. QMS Management
   · Develop, implement, and maintain SMI’s Quality Management System (QMS) in alignment with ISO 13485 and other relevant standards.
   · Lead efforts to achieve and maintain ISO 13485 accreditation, including preparing for certification audits and addressing any findings.
   · Establish and monitor quality objectives and key performance indicators (KPIs) to assess the effectiveness of the QMS.
   · Conduct regular internal audits to ensure compliance with regulatory and organisational requirements.
   · Coordinate and lead management reviews to identify areas for quality improvement and ensure alignment with strategic goals.
   · Provide training and support to staff to promote a culture of quality and ensure understanding of QMS processes.
   · Oversee document control processes, ensuring all quality-related documentation is up to date and accessible.
   · Work collaboratively with external regulatory consultants to align QMS processes with best practices and regulatory expectations.
   · Manage non-conformance investigations and implement corrective and preventive actions (CAPAs) effectively.
   · Liaise with external auditors and regulatory bodies to facilitate inspections and certifications.
2. Regulatory progress
   · Prepare and submit regulatory filings, including, but not limited to, technical documentation, UKCA, CE Mark submissions, and 510(k)s as applicable.
   · Maintain up-to-date knowledge of regulatory requirements in the UK (UKCA), EU (MDR), USA (FDA), and other international regions.
   · Collaborate with cross-functional teams to gather required data and documentation for regulatory submissions.
   · Work in partnership with external regulatory consultants to navigate complex regulatory pathways and resolve challenges.
   · Act as a primary point of contact for regulatory agencies, responding promptly to inquiries and managing feedback.
   · Monitor post-market surveillance and compliance activities to ensure ongoing adherence to regulatory requirements.
   The job holder will also be expected to fulfil other reasonable duties as required to support the operation.