Senior Ra Specialist - Birmingham, United Kingdom - Nonacus Limited

Nonacus Limited

Verified Company

Birmingham, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Senior RA Specialist

Perm

Birmingham

Nonacus Ltd, is a privately held company developing innovative molecular diagnostics products, combining software and reagents, for the International clinical market.

We specialise in the use of cell free DNA to inform clinical decisions with a particular focus on post-treatment cancer surveillance via liquid biopsy.

Purpose Statement

The
Senior RA Specialist will support the company's regulatory responsibility for the genomic IVD product applicable regulations, standards and country specific requirements, to enable and support the commercial registrations strategy for market access.

The position requires excellent IVD regulatory knowledge and communication skills, to support internal and external customers, support for business process improvements with sound knowledge of ISO13485, including regulatory submissions controls, full compliance for regulatory and quality related activities to the latest state of the art Global Regulatory requirements.

Key responsibilities

Liaise with the company leads to plan, manage and execute regulatory activities for the commercial global mapping/delivery of certified products and ongoing maintenance support
Creation, management and maintenance of Technical Files / Medical Device Files
Genomic product lines and software
Manage relationships and have excellent communication skills working with regulatory agencies / authorised representatives and also when sharing regulatory data/information to the internal teams
Hands on approach to assessing impact of new and updated regulatory requirements and planning to cover the key change controls with internal and external stakeholders.
Support the regulatory requirements for New Product Development process, contributing to product validation plans, reports, product technical claim support papers and post market planning.
Retrospective review of product files for updates, as required
Product risk management support with the Quality Manager
Experience with Clinical and Performance Evaluation Report generation
Marketed product controls post market surveillance, Medical Device reporting/vigilance/product recall and withdrawal events, liaising with internal leaders, regulatory authorities and external stakeholders.
IFU translation support for new product development and changes for technical file compliance
Support notified body audits, third party audits, as appropriate
Generate and support Regulatory Training to internal teams

Job Qualifications & Skills

Minimum of 5 years experience in Regulatory Affairs within IVD, diagnostics and/or life sciences.
Degree in a life science or equivalent either in genetics or molecular biology and significant experience working within regulatory affairs.
Experience of country registration processes for global commercial support
Strong knowledge, experience and support including submissions, with IVDD, IVDR, MDSAP, planning
Experience directly working with the FDA or other regulatory bodies, through the submission process, to resolve on market issues and maintain product approvals.
Strong knowledge and experience of implementing QMS ISO 13485 regulations
Experience of involvement with Notified Body Audits
Excellent organisational skills and an ability to work to tight timelines and support multiple projects.
Selfconfident with ability to work well under pressure
Computer literate with a good understanding of laboratory systems.

Company Values
Our core values stem from being patient and customer centric, collaborative and innovative in our approach.

As a company, we strive to deliver innovative genomic technologies which advance liquid biopsy diagnostics and improve cancer patient outcomes worldwide.

Patient and customer-centric, equitable, collaborative, innovative and accountable

Behaviour Statements

Integrity is central to Nonacus employee behaviour, this is exhibited through being honest and open with our colleagues and customers.

By acting professionally and respectful in all matters we ensure that we are a company that say what we mean and deliver what we say.

Nonacus care about its staff and their well-being. We are committed to providing the support to maintain good physical and mental health. As colleagues we care and are empathetic to each other.

Nonacus staff are dedicated to improving patient care through innovation.

By listening to each other and our customers, clear communication and being open minded we create solutions that will ensure we deliver on our mission.

Job Type:
Permanent

Salary:
£45,000.00-£55,000.00 per year

Benefits: