Global Compliance Solutions Lead

5 days ago


Belfast, United Kingdom ARC Regulatory Ltd Full time
About Us

ARC Regulatory Ltd is a leading provider of compliance solutions to the pharmaceutical and biotechnology industries. Our team of experts has extensive experience in regulatory affairs, quality assurance, and clinical operations, and we are dedicated to helping our clients navigate the complex regulatory landscape.

We are seeking a highly experienced Regulatory Affairs Specialist to join our team in Belfast. As a key member of our compliance solutions delivery team, you will play a critical role in ensuring that client companies meet their regulatory obligations and objectives.

The ideal candidate will have a strong background in IVD/CDx development, validation, and approval, with experience in leading global regulatory submissions and developing technical documentation. You will be responsible for providing expert strategies and guidance to client companies, as well as preparing elements of regulatory submission documents, including IVDR Annex XIV applications, CTAs, and study risk determination requests.

This is an exciting opportunity for a motivated and detail-oriented individual to join our dynamic team and contribute to the growth and success of ARC Regulatory Ltd. We offer a competitive salary range of £80,000 - £100,000 per annum, depending on experience, as well as opportunities for professional development and advancement.

Key Responsibilities:
- Provide regulatory expertise to client companies, ensuring compliance with global regulations
- Develop and implement global regulatory strategies for IVD devices
- Prepare and submit regulatory documents, including IVDR Annex XIV applications and CTAs
- Collaborate with cross-functional teams to ensure effective implementation of regulatory requirements

Requirements:
- Engineering or Scientific honors degree or equivalent (10+ years) relevant industry experience
- 5+ years experience 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
- Experience leading global regulatory submissions (e.g. EU/FDA)
- Experience developing and maintaining technical documentation (IVDD/IVDR) or design history file documentation (FDA)

Benefits:
- Competitive salary range of £80,000 - £100,000 per annum
- Opportunities for professional development and advancement
- Collaborative and dynamic work environment
- Flexible working arrangements and remote work options

We are committed to attracting and retaining top talent, and we offer a comprehensive benefits package that includes health insurance, retirement plans, and paid time off.

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