Quality Assurance, Regulatory Affairs and Compliance Manager - medical devices / SaMD, Ref: 109

Quality Assurance, Regulatory Affairs and Compliance Manager – medical devices / SaMD, Ref: 109

Role Type

Quality Assurance, Regulatory Affairs, Compliance Manager – medical devices / SaMD / MedTech

Skills / Experience

Quality Assurance, Compliance, Regulatory Affairs, ISO27001, ISO13485, UK MDR, medical devices, medtech or healthtech start-ups

Availability

Officially 3 months notice but likely able to reduce

Contract Preference

Permanent (ideally). Would possibly consider a contract role

Salary / Rate Expectation

£65k – £70k

Profile

With a passion for healthcare, career goals are underpinned with the aim of making a positive impact to the lives of patients/service users, ensuring that they receive the therapy they require to live a somewhat normal and fulfilling life.

Has had the opportunity to work in a mixture of healthcare related businesses including Pharmaceuticals, Orthopaedics and a Medical Imaging start-up using AI. Currently working for a start-up who are developing the world’s most comprehensive cancer therapy monitoring solution, combining innovative at-home blood testing technology and digital solutions to help doctors deliver more personalised care to patients. From these experiences, has been able to:

Develop my interpersonal skills by working with colleagues from different functions and adapting to the ever-changing highs, lows and unpredictability of working in a start-up environment
Understand the impact of producing high quality work on both day-to-day business and the end user (often patients and medical professionals)
Grow as a Quality & Regulatory Professional helping businesses to achieve, maintain and improve compliance with regulatory and legal requirements to ensure the delivery of a safe and effective product

Experience

Quality Manager – MedTech Start-up

Sept 2024 – present

Reporting to the COO, current responsibilities include (but not limited to):

Acting Management Representative and team lead for company-wide quarterly planning
Maintaining and improving the QMS: Objectives/KPIs, review and approval of quality, medical device and (as required) clinical trial management system documentation, internal training, supplier quality and management reviews
Planning & executing internal audits and hosting external surveillance & re-certification audits
Developing and continuously improving policies, procedures, work instructions and workflows
Liaising with Certification/Approved Body (BSI)
Supporting UKCA and US FDA 510(k) activities
Reg intel & performing gap analyses for new/updated regs (e.g., UK MDR 2002 Part 4a PMS & Vigilance, ISO 27001:2022)

Quality Assurance & Compliance Manager

Feb 2020 – Sept 2024

Reporting into the Chief Operating Officer, my responsibilities included:

Day-to-day QMS & ISMS management
Leading on NC/CAPA, Change Control and Design Changes, Software Validation, Internal & External Audits (Surveillance & Re-Certification), Employee Training, Supplier Management, Management Review
Leading the development and improvement of internal policies, processes, procedures, work instructions & workflows
Monitoring & reporting on QMS/ISMS objectives and KPIs
Acting Management Representative and eligible PRRC
SharePoint QMS to a cloud based eQMS system transition
Medical Device File management and administration
Working with Certification & Notified Bodies (BSI & LRQA), Competent Authorities (MHRA)
Supporting CE, UKCA and 510k submissions
Leading on Risk Management activities
Work with interested parties throughout the business to support compliance activities relating to:

– EU MDD and the transition to EU MDR
– 21 CFR Part 820
– ISO 13485:2016
– ISO 27001:2013 and the transition to ISO 27001:2022
– ISO 14971:2007 and the transition to ISO 14971:2019
– IEC 62304:2006
– UK Data Protection Act 2018 & EU GDPR
– NHS DSPT
– HIPAA
– Information Governance & Information Security

Regulatory Affairs & Quality Assurance Engineer

Nov 2017 – Feb 2020

Working alongside the RAQA Manager, was responsible for the day-to-day management of an ISO 13485, 93/42/EEC (MDD) and FDA 21 CFR 820 compliant Quality System. Highlights included:

Assisting in the transition from ISO 13485:2012 to ISO 13485:2016
Overhauling the Change Management and Complaints processes to better align with regulatory and business requirements
Creating and Updating procedures and processes required for an effective and efficient QMS
NC & CAPA Management
Maintaining and updating DMRs and Technical Files
Training key personnel on QMS Procedures and processes
Carrying out Raw material & Finished Goods Inspection and Release
Processing Customer Complaints & Customer Feedback
Carrying out Internal Audits and supporting External Supplier Audits (Domestic and International) and 3rd party notified body audits
Promoting the importance of Quality, embedding a culture of continuous improvement and ownership of processes

Regulatory CMC Associate

Sept 2015 – Nov 2017

Worked on the regulatory aspects of AstraZeneca owned medicinal products marketed in Europe, Middle East, Asia, Africa and South America, across a range of therapy areas. Responsibilities included:

Reviewing and approving Regulatory CMC documents
Project managing timely submission of post approval CMC documentation
Coordinating the assembly/generation of submission-ready components to support lifecycle submissions
Working in partnership with global stakeholders across AZ, including Global Regulatory Affairs, Pharmaceutical
Development, Marketing Companies, Operations, Scientists and Manufacturing
MAAs, Variations and Licence Renewal submissions

For further information on this candidate please use reference number: 109

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