Project Co-Ordinator (Regulatory & Compliance) London, England
Job description
About us!
We are a digital health company transforming the way that surgery is delivered. Our team is building intelligent technology that allows surgeons to treat more patients, safer – whilst improving clinical outcomes, patient experience and reducing the cost of care.
msk.ai launched in 2016 and is growing rapidly, being live with leading orthopaedic surgeons and centres across the UK, Europe, Australia & US with plans for further expansion within NA & APAC. In 2022 we were acquired by HOPCo (https://hopco.com/), the US leader in musculoskeletal physician practice management, outcomes management and value-based care solutions, and we are now focused.
Role
We are looking for an aspiring Project Manager to support our Quality & Regulatory Compliance Team.
We are shaping the future of healthcare and you will play a key role in ensuring that our digital health solutions are safe, effective and helpful to both patients and healthcare professionals.
You will diligently oversee the development, implementation and compliance of our product offerings, including the myrecovery app and the msk.ai web dashboard with information security frameworks including HITRUST and ISO 27001.
You will help to maintain safety and quality by ensuring compliance with ISO 13485 and FDA Quality System Regulation (QSR) across a growing portfolio of Software as Medical Device (SaMD) and AI as Medical Device (AIaMD) digital health products.
The role comes with an annual training package with a wide selection of relevant courses, including training from the British Standards Institute (BSI), e.g. Introduction to Medical Device Software, Requirements of the Medical Device Regulation for CE Marking and ISO 13485 and ISO 27001 internal auditing).
Responsibilities
- Assist in the upkeep of the msk.ai Quality Management System (QMS), meeting ISO 13485, FDA QSR, EU MDR, and other pertinent standards.
- Support the continuous improvement of the QMS through regular monitoring for compliance and performance.
- Performing internal audits of the msk.ai information security and quality management systems
- Assist in the coordination of external audits, helping to ensure timely completion of any necessary corrective and preventive actions.
- Collaborate with various teams to support product risk management activities in line with ISO 14971.
- Following training, provide regulatory guidance to cross-functional teams during the product development cycle.
- Assist in the preparation and review of technical files and design dossiers.
- Support the implementation of compliance training for all pertinent employees.
- Stay informed about regulatory changes and assist in the implementation of required modifications to compliance programs.
Requirements
- Experience (1-2 years minimum) of working with processes and procedures in a corporate or civil service environment
- Bachelor's degree in a related or equivalent experience. Holding an advanced degree or relevant certification would be an advantage.
- A working knowledge of one or more of the following ISO 27001, ISO 13485, HITRUST, HIPAA, GDPR, DCB 0129, and other regulations applicable to digital health and SaMD is an added bonus!
- Strong problem-solving abilities and attention to detail.
- Excellent written and verbal communication skills.
- Experience of working with Google Workspace is a plus.
- Experience in participating in internal and external audits.
What We Offer
- Competitive salaries
- Enhanced Company Pension - matched 5% contribution of full earnings
- Annual training budget
- Cycle to work scheme
- Flexible working arrangements
- Work-from-home setup allowance
- Access to a modern, dog-friendly office space for those preferring a traditional work environment
- 25 days of holiday plus bank holidays,
- Amazing Opportunities for career growth at rapidly growing company
We champion diversity and are committed to fostering an inclusive work environment for all employees.
Flexible Working
We offer the flexibility to work in a hybrid work environment, with the requirement to be in the Aldgate East office once a week, for this reason we suggest candidates are within commutable distance to London. This setup allows you to balance your work and personal life effectively. Moreover, we are open to discussing reduced hour arrangements for motivated and suitably experienced candidates.
Job Type: Full-time
Salary: £30,000.00-£40,000.00 per year
Benefits:
- Company pension
- Cycle to work scheme
- Work from home
Schedule:
- Monday to Friday
Work Location: Hybrid remote in London
Application deadline: 26/09/2023
Reference ID: PC190923
