We lead the market with an array of exciting, cutting edge solutions dedicated to delivering digital Healthcare specifically remote patient monitoring and telehealth.
Due to continued growth, we require a permanent full-time Regulatory Compliance Specialist to ensure our business remains compliant to the standards and regulations required within the medical arena.
You will have a significant role working as part of a small team focused on maintaining compliance to the changing regulations across UK and EU, with responsibility for maintenance of all technical files to MDD, MDR and UKCA.
Senior Regulatory Compliance Specialist – Digital Health App
Bookham, Surrey or home based
The Senior Regulatory Compliance Specialist Role:
We lead the market with an array of exciting medically approved devices dedicated to delivering telehealth services within the digital healthcare market. With healthcare pressures demanding innovative technological solutions and with a greater move to telehealth delivery services, you can directly contribute to this rewarding area of medical services; become a valued team member and ultimately help improve the effectiveness of community-based care.
Be part of our ongoing success and get excited when using your knowledge and professionalism to help improve other people’s lives.
This is a great opportunity to strengthen our operational robustness, help us grow and enjoy a relaxed yet stimulating working environment within this very satisfying and lucrative industry.
+ Responsibility for preparation and submissions of regulatory applications and registrations.
+ Point of contact for competent authorities.
+ Create, modify and maintain device Technical Files.
+ Project manage and undertake transitional activities for Technical Files from MDD to UKCA and MDR within next 12-18 months.
+ Provide regulatory subject matter expertise to support business activities as required.
+ Manage and address any audit device technical file non-conformities.
+ Ensure regular collection of evidence for the annual Clinical Evaluation and Post Market Surveillance Reports and create the reports.
+ Maintain a knowledge of the changing regulatory standards and implement the changes necessary.
+ Deliver the supporting RA documentation required for sales Frameworks and Tender responses.
+ Manage and support the internal and external regulatory resource.
+ Be the internal resource to undertake internal audits for ISO 27001.
+ Maintain security, integrity, and the confidentiality of data.
+ Be the first point of contact for anyone in the team seeking technical assistance.
+ Responsible for handling support of requests which relate to all technology including; workstations, servers, printers, networks, and system accounts.
+ Managing the day to day operation of the varying backup solutions in place.
+ Provide remote and telephone support for client networks and applications.
+ Hands-on, sleeves rolled up, willing to write and update regulatory and technical documentation and complete the required regulatory submissions.
+ Take a pragmatic view.
+ Take responsibility and drive activities.
+ Work effectively, both independently and as part of a team and develop, maintain and work to defined project plans and have a structured and methodical approach.
+ Have excellent verbal and written English and have reporting and presentation skills.
+ Technical background within medical devices with an in-depth understanding of the regulatory function, with good knowledge of related quality, engineering, clinical, safety, and post-market functions.
+ BS University degree, Life/Health Sciences preferred.
+ 3 years plus Regulatory Affairs experience within the Medical device sector.
+ Strong understanding of MDD, MDR and the transition process.
+ Good working knowledge of EN 62304, having maintained electronic and software devices Technical Files.
+ Experience in the production and maintenance of documentation supporting NHS DCB0129/0160.
+ To fulfil the above you will require an up-to-date working knowledge of the following:
++ MDD and MDR (Class 1 & 11a devices)
++ BS EN ISO 13485, 14971, 14155, 27001
++ BS EN IEC 60601
++ BS EN 62304
++ NHS DCB0129 / DCB0160
Interested? Apply here for a fast-track path to the Hiring Manager
If you have any pre-application questions please contact us first quoting the job title & ref. Good luck, Team RR.