Senior Regulatory Compliance Specialist – Health App. Remote Ref: 15447

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.

Role Info:

Senior Regulatory Compliance Specialist – Digital Health App
Bookham, Surrey or home based
£competitive
Plus Pension

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.

Key Responsibilities:

+ 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.

About You:

+ 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.

Key Competencies:

+ 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
++ GDPR

Interested? Apply here for a fast-track path to the Hiring Manager

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If you have any pre-application questions please contact us first quoting the job title & ref. Good luck, Team RR.