Senior Regulatory Affairs Associate

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Job Overview

The role of Senior Regulatory Affairs Associate with Walker Cole International based in Scotland is a significant opportunity for seasoned professionals in the In Vitro Diagnostics (IVD) sector. The position offers a hybrid work model, allowing for a blend of remote and in-office tasks, which can be highly beneficial for maintaining work-life balance while contributing to impactful diagnostic products.

Responsibilities

As a Senior Regulatory Affairs Specialist, the major responsibilities will revolve around managing and supporting regulatory affairs activities throughout the lifecycle of IVD products. Some of the key tasks include:

• Leading and supporting Regulatory Affairs activities for various IVD products. This includes navigating through complex regulatory landscapes and ensuring compliance with EU IVDR, UKCA, and FDA regulations.

• Preparing, reviewing, and maintaining IVD regulatory submissions. This involves compiling technical documentation and regulatory files necessary for market authorization and ongoing compliance.

• Acting as a key point of contact within the organization, liaising with Notified Bodies, competent authorities, as well as internal stakeholders to relay regulatory expectations and requirements.

• Supporting the development of regulatory strategies for both new and existing IVD devices, ensuring alignment with current regulations and market needs.

• Ensuring compliance with pertinent standards like ISO 13485 and keeping current with relevant guidance documents.

• Collaborating with cross-functional teams across Quality, R&D, Clinical, and Product Development, which enhances the integration of regulatory considerations in product design and lifecycle management.

• Engaging in post-market activities, including oversight of change control processes, vigilance, and overall lifecycle management.

• Continuously improving Regulatory Affairs processes and documentation to streamline efficiency and effectiveness in compliance activities.

Required Skills

To succeed in this role as a Senior Regulatory Affairs Specialist, candidates should have the following experience and competencies:

• Proven experience in Regulatory Affairs specifically within an IVD / In Vitro Diagnostics environment.

• A strong working knowledge of EU IVDR, UKCA requirements, as well as broader IVD regulatory frameworks.

• Practical experience in compiling and maintaining IVD technical files and regulatory submissions.

• Confidence in working collaboratively with Notified Bodies and relevant regulatory authorities, showcasing interpersonal skills and negotiation capabilities.

• Excellent communication, organization, and stakeholder management skills to navigate complex regulatory discussions and ensure alignment across teams.

Salary Information

Currently, there is no specified salary information mentioned for this role, which might vary based on the experience level of the candidate and industry standards for similar positions within the IVD sector.

Work Environment

This position is characterized by its hybrid nature, meaning that while it provides flexibility with remote working opportunities, there may still be a requirement for on-site engagement to collaborate directly with the regulatory team and engage with other departments effectively.

Career Development

The Senior Regulatory Affairs Specialist role at Walker Cole International is positioned as a pivotal role within a growing IVD company, offering ample opportunities for professional growth. As the organization expands its product portfolio and navigates new regulations, this position allows for substantial engagement with innovative In Vitro Diagnostic products, enabling career advancement in Regulatory Affairs.

Therefore, this role is likely to appeal to those who not only meet the required expertise but also have a passion for advancing in the field of medical devices and diagnostics, contributing to enhancing patient care through innovation.

This job offer was originally published on jooble.com