Regulatory Affairs Specialist

Responsibilities

We are representing a confidential product development consultancy seeking a Regulatory Affairs Specialist to join their quality assurance team on a remote basis. In this role, you will provide regulatory support across multidisciplinary project teams spanning medical devices and other regulated products.

Your day-to-day responsibilities will include:

• Applying your compliance expertise in product regulations and quality standards (ISO 9001:2015, ISO 13485:2016, FDA QMSR 21 CFR 820) to provide strategic guidance on client projects while expanding knowledge of European, US, and Asian regulatory frameworks
• Monitoring and interpreting key changes in international regulations, guidance documents, and standards, then communicating implications to internal teams and stakeholders
• Leading communications on quality and regulatory updates and driving internal improvement initiatives as a technical subject matter expert
• Supporting external audit preparation and execution in collaboration with quality assurance colleagues
• Facilitating project team work through strong leadership and project management capabilities
• Maintaining quality management system documentation with meticulous attention to detail and a collaborative approach to process improvements
• Developing pragmatic solutions that balance innovation with regulatory rigour under commercial, technical, and time constraints
• Contributing regulatory expertise to projects with varying disciplines, scale, and complexity

What We're Looking For

Our talent team is seeking a candidate who demonstrates:

• Clear thinking with the ability to work independently, flexibly, and inventively while showing leadership in managing activities
• Proactive communication skills and relationship-building capabilities across diverse stakeholders
• Ownership mentality with a focus on delivering results and driving continual improvement
• Proven track record of developing and executing regulatory strategies that align with business objectives and deliverables
• Skill and experience interpreting regulatory and standard requirements to clarify downstream process implications
• Knowledge of medical device compliance requirements

How We Work With You

When you apply through Get A Job.ai, our recruiting team will review your application and conduct an initial screening to understand your experience and career goals. If there's a strong match, we will submit your profile to our client for consideration. Please do not contact the client directly, as all communication regarding this opportunity should flow through our team to ensure a smooth process for everyone involved.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Get A Job.ai is an equal opportunity recruiter. We celebrate diversity and are committed to creating an inclusive environment for all candidates we represent.