Quality and Regulation Officer
Experience level: Mid
Compensation: £30,000 – £50,000
Employment Type: Permanent
Remote working: No (on-site)
Visa sponsorship: Available
Machine Medicine Technologies (MMT) uses computer vision and computational statistics to enhance the neurological assessment of patients. Our first product, KELVIN, allows motor assessments in Parkinson’s disease to be performed, recorded and used both faster and better than has ever previously been possible. KELVIN-PD is already in use at clinical sites across several countries and possesses a CE mark, being a class-I medical device. MMT aims to build the platform into a generalised tool for patient selection, surgical planning and device programming for machine brain interfacing, a revolutionary therapeutic innovation.
A fast-moving startup, with an energetic and dynamic team, looking to disrupt the MedTech industry with AI. Our employees are encouraged to take on the sort of career development opportunities that cannot be found at larger, more established, companies. We are in the highly regulated medical device industry, so our engineering team has to have an even greater focus on quality, usability and versatility. We also like to blow off steam, whether that’s playing a few rounds of table tennis in the office, or arranging an online gaming session.
- Competitive salary
- 25 days annual leave (+8 bank holidays)
- Offices close to London Bridge, Bermondsey Street and Borough Market
You are an ambitious and intelligent professional with at least 3 years of experience in regulatory and compliance management in the medical devices industry, particularly medical device design and development. You enjoy learning new things, are solution-focused and happy at the interface of technical, legal, and regulatory development. Impact matters to you.
List of main duties and responsibilities:
- Assisting our Head of Quality and Regulation in authoring and reviewing medical device technical documentation/design history files/device master files according to requirements:
- UK MDR.
- EU MDR (CE Marking).
- U.S. FDA Premarket Notifications (510(k)).
- Maintain and organise the company’s QMS and ISMS including:
- Compiling new, and updating existing SOPs and policies as needed.
- Management of Change Control Approvals and CAPAs.
- Management of supplier approvals and reviews.
- Compiling and updating risk management documentation as needed.
- Preparation of, and participating in, Management Reviews and following up on actions.
- Participating in, and potentially conducting internal audits, following up on NCs.
- Participate in external regulatory and customer audits.
- Conducting training as needed.
- Remain up to date on changes to country-specific regulations, updated standards/guidance documents, industry trends, internal processes and business goals.
- Bachelor’s degree in quality management/regulation or related field (medical, scientific or engineering).
- Minimum of 3 years’ experience as a Quality or Regulatory professional in the medical devices industry.
- Knowledge and experience in Quality Management Systems (ISO 13485).
- Knowledge and experience in compiling/reviewing medical device technical documentation/design. history files/device master files for regulatory submissions in either the EU, UK or U.S.
- Ability to independently research and summarise findings.
- Strong written and verbal communication skills.
- Proven experience in data reporting and working accurately with sensitive data.
- Existing knowledge of regulatory and/or legal environment for UK medical device industry.
- Experience with Medical Device Software validation (ISO 62304).
- Experience with Information Security (ISO 27001).
- Experience specifically with FDA submissions (510k) will be highly advantageous.
- An ISO 9001 or ISO 13485 internal/supplier/lead auditor certification will be highly advantageous.
Job reference no. QRO152