Senior Specialist – Regulatory Affairs (IVD and CDx)

Job Title: Senior Specialist – Regulatory Affairs (IVD and CDx)

Salary: £ DOE

Job Purpose

To be an integral member and significant contributor to project team(s) in the development and delivery of global compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times. This will require the utilisation of a platinum standard approach to regulatory research, internal and external stakeholder satisfaction as well as an innate work ethic and attention to detail that is aligned with the company’s core values.

A day in the life of a Regulatory Affairs Associate (IVD & CDx) at ARC includes:

Support the work of the company and project teams in the provision of specialised regulatory expertise to client companies, ensuring that internal procedures and client expectations and interests are met.
Bring considerable experience in IVD/CDx development, validation and approval to client organisations, providing expert strategies and guidance to their development programmes.
Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to IVDR Annex XIV applications, CTA’s, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc.
Assist wider team in understanding the regulatory requirements for an investigational device in the set-up, management & conduct of IVD performance studies/clinical investigations worldwide (e.g. IVDR and 21 CFR 812 requirements).
Manage and keep up to date information relating to global regulatory requirements for IVD devices and maintain the company’s web-based clinical trial planning tool.
Conduct gap analyses on behalf of client companies and prepare associated reports (e.g. technical documentation/design history files).
Contribute to the preparation of global guidance documents and white papers.
Contribute to the preparation of other regulatory documents on behalf of client companies (e.g., Performance Evaluation Plans/Reports, Investigator Brochures, etc).
As required, take advantage of professional networking opportunities to promote the company and its services to appropriate parties.
Design and deliver formal client presentations, including proposed solutions and client training. Prepare and deliver presentation(s) relevant to the company’s regulatory support offerings at industry meetings and conferences.
Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards.
Contribute to ARC company culture initiatives to maintain a positive and engaging workforce.
Any other duties, within reason and capability, as determined by company management.

Qualifications/ Attainments

Essential

Engineering or Scientific honours degree or equivalent (10+ years) relevant industry experience

Desirable

MSc or PhD in science related subject

Relevant Knowledge and Experience

Essential

5+ years’ experience of working in a medical device/IVD manufacturing or regulatory environment
Experience with IVD/CDx design and development, from feasibility to approval
Knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices (e.g. EU/US)
Experience of leading global regulatory submissions (e.g. EU/FDA)
Experience developing and maintaining technical documentation (IVDD/IVDR) or design history file documentation (FDA)
Experience developing global regulatory strategies for IVD devices

Desirable

Experience of regulatory requirements for companion diagnostics (CDx) in US or EU
Experience in assisting, from a regulatory perspective, the set-up of global clinical investigation sites, including submissions relating to IVD performance studies/clinical investigation
Experience of conducting literature research using scientific publications with the aim of demonstrating a hypothesis or to support the need for a clinical investigation
Knowledge of regulatory requirements in emerging markets (e.g. Asia/South America)

Skills and Competencies

Excellent interpersonal skills
Excellent communication skills, both verbal and written, including strong presentation and influencing skills
Evidence of strong analytical, problem solving and decision-making abilities
Evidence of well-developed organisational, planning and time management abilities
Proven ability to achieve results while working independently and on own initiative
Strong mathematical ability
Proficient in the use of word processing, spreadsheet, database, and presentation software

Circumstances

Able to work flexibly as required to ensure business needs are met
Valid full driving licence and vehicle insured for business use
Able to travel extensively as required, including European and possibly global travel
Valid passport

Closing Date: Friday 13th of September 2024 at 5PM

Working at ARC

Competitive salary
30 days of annual leave (incl. Public Holidays), increasing to 35 in 1-day annual increments
Employer contributory pension scheme
Employee Benefits Program (after probation period)
Office situated at the Catalyst site in Belfast at the heart of innovation in the region
Hybrid working model (after probation period)
Budget available to support training needs

We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.