Quality & Compliance Manager, HOPCo

Part-time

£40-60k

Salary is FTE. This is a part time role with 2/3 days a week, or the equivalent hours spread over 4/5 days

Mid and Senior level

London

Remote from UK

Pathway-specific digital companions for orthopaedic surgery, musculoskeletal care & beyond

Job no longer available

Pathway-specific digital companions for orthopaedic surgery, musculoskeletal care & beyond

21-100 employees

HealthcareB2CB2BAnalyticsMobileData AnalysisScienceMedTech

Job no longer available

£40-60k

Salary is FTE. This is a part time role with 2/3 days a week, or the equivalent hours spread over 4/5 days

Mid and Senior level

London

Remote from UK

21-100 employees

HealthcareB2CB2BAnalyticsMobileData AnalysisScienceMedTech

Company mission

Unlocking value for physicians, health systems, and health plans through technology.

Job

Company

Role

Who you are

Minimum of 5 years' experience in quality assurance and regulatory affairs in the digital health/medical device industry or similar
Bachelor's degree in a related field (or equivalent experience). Advanced degree or relevant certification will be a plus
Familiarity with ISO 27001, ISO 13485, HITRUST, HIPAA, GDPR, DCB 0129, and other applicable regulations
Experience in conducting and managing internal and external audits
Strong problem-solving skills and attention to detail
Excellent written and verbal communication skills

What the job involves

As our Quality and Compliance Manager, you will be responsible for the development, implementation, and maintenance of quality assurance systems and activities, and ensure our compliance with local and international regulatory standards applicable to our non-medical device and Software as Medical Device (SaMD) products
Maintain a robust Quality Management System (QMS) that meets ISO 13485, FDA QSR, EU MDR, and other relevant standards
Drive the maintenance and continuous improvement of the QMS, ensuring compliance and performance
Manage internal and external audits, and ensure timely completion of any necessary corrective and preventive actions
Interface with regulatory agencies during inspections and support regulatory submissions
Participate in product risk management activities in line with ISO 14971
Provide regulatory guidance to cross-functional teams during the product development cycle
Assist in the development and review of technical files and design dossiers
Implement and oversee compliance training for all relevant employees
Maintain up-to-date knowledge of regulatory changes and implement required modifications to compliance programs

Application process

1. Apply via Otta
2. Video chat with Senior Team Member
3. In person interview with Chief Security Officer

Salary benchmarks

Our take

The strain placed on healthcare systems over recent years has galvanised substantial and necessary changes in the way these institutions operate. One of them is remote patient monitoring. HOPco’s app allows patients to remotely connect with their care providers easily and frequently, recording their own recovery data and outcomes. These data sets become insights, which are subsequently shared with major orthopaedic research institutions worldwide.

It’s a neat win/win dovetail on HOPco's part, one that addresses patients’ need for on-demand, quality care, and researchers’ need to underpin their work with broad, real-world data sets. Some scepticism has been voiced among both caregivers and patients about the relative quality of telemedical care. However, the lengthy patient backlogs and surgery cancellations of recent years have highlighted that offering remote healthcare options is, for many, not an option but a necessity.

Steph

Company Specialist at Welcome to the Jungle

Insights

35% female employees

Glassdoor (4.4)

Company

Company benefits

25 days paid holiday, plus bank holidays
Hybrid working
Training budget for professional development
Enhanced Company Pension Scheme (up to 5% matched on full earnings)
Cycle to Work Scheme
Flexible working arrangements
Dog Friendly office
Private Health Insurance

Leadership

Tom Harte

(Co-Founder)

A surgical doctor who trained at the Royal College of Surgeons and the University of Manchester.

Axel Sylvan

(Co-Founder & Chief Clinical Information Officer)

Has held various medical roles at Whittington Health, Queen Mary University, Doctors of the World, and - just prior to co-founding msk.ai - was a paediatric surgeon at Great Ormond Street Hospital.

Share this job