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Senior Regulatory Compliance Specialist – Health App. Remote

Employer
Recruitment Revolution
Location
London
Salary
Attractive - negotiable
Closing date
1 Dec 2021

View more

Sector
Technology & New Media, Healthcare
Salary Band
Annual, £40,000 - £49,999, £50,000 - £59,999, £60,000 - £69,999, £70,000 - £99,999
Contract Type
Permanent
Hours
Full Time
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Job Details

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

Application notice… We take your privacy seriously. When you apply, we shall process your details and pass your application to our client for review for this vacancy only. As you might expect we may contact you by email, text or telephone. Your data is processed on the basis of our legitimate interests in fulfilling the recruitment process. Please refer to our Data Privacy Policy & Notice on our website for further details.

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

Company

We’re Talent Acquisition Specialists that founded change in 2005. Since then we’ve helped over 2500 clients grow, prosper and lead.

# Our Story

Frustrated by poor experiences with traditional agencies, our founders (just two regular candidates), decided that the outdated industry needed modernising and a new balance of power. In 2005, a new kind of agency model was born, putting the client and candidate at the heart of the experience whilst removing the pushy sales, schmooze and high fees.

# What makes us different?

Aside from a sensible fee model, custom technology and a direct unhindered path to candidates we…

…don’t sell candidates and we don’t sell jobs: we facilitate relationships and champion the process of ‘organic hiring’ to help create stronger and longer-lasting engagements.

# Who we work with

With an industry reputation for delivering results we are the go-to talent finders for over 2500 clients. We work with everyone from tech start-ups to global brands who all demand the best service and talent.

From business owners hiring 2 people a year to Internal Recruiting teams hiring 200+ people a year, RR sources talent across all sectors and levels.

# Reputation

Our expertise have also been called upon by some of the leading job boards including the UK’s No1. Reed.co.uk.

Recruitment Revolution is a member of the REC with a 100% compliance pass rate and holds a Feefo 5* Gold Award for Service.

For more information please contact Team RR on 0800 294 3113 or visit https://www.recruitmentrevolution.com

Find Us
Website:
Telephone
01344844064
Location
Castle Hill House
12 Castle Hill
Windsor
Berkshire
SL4 1PD
United Kingdom
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