Regulatory Affairs Specialist

HIRANI; Belfast City District; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

ARC Belfast is seeking an experienced Regulatory affairs / Quality Assurance lead to deliver global compliance solutions for IVD devices and CDx products. You will prepare regulatory submissions, review quality systems, and advise across multiple markets, balancing client needs with regulatory expectations.

Requires 5+ years in a medical device GMP/GLP environment, engineering or science degree, and strong communication and analytical skills.

Qualifications

• Engineering or Scientific honours degree or equivalent relevant industry experience.
• 5+ years’ experience in a medical device GMP/GLP environment.
• Knowledge of regulations in key global markets for IVD/CDx devices (EU/US).
• Excellent interpersonal and communication skills, with strong presentation abilities.

Responsibilities

• Support regulatory and quality assurance work for client companies and projects.
• Prepare regulatory submission elements (IDE, 510(k), PMA, CE files, etc.).
• Research regulatory requirements for IVD performance studies and maintain planning tools.
• Create global guidance documents and white papers.
• Deliver client presentations and training on regulatory topics.

Skills

Regulatory affairs

Quality assurance

GMP/GLP

Regulatory submissions

Stakeholder management

Education

Engineering or Science degree

Job description

ARC’s purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients.

We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world’s leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients’ IND/IMP trial.

ARC’s team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable.

To further support our growing client base and to expedite patient access to life‑saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study‑specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting‑edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.

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.

Key Responsibilities:

Support the work of the company and project teams in the provision of specialised regulatory and quality assurance expertise to client companies, ensuring client expectations and interests are met.

Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to 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 worldwide

Manage and keep up to date information relating to regulatory requirements for IVD performance studies and maintain the company’s web‑based clinical trial planning tool.

Conduct gap analyses on behalf of client companies and prepare associated reports.

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.

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.

Engineering or Scientific honours degree or equivalent relevant industry experience

5+ years’ experience of working in a medical device GMP/GLP environment

Knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices (e.g. EU/US)

MSc or PhD in science related subject is desirable

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