Regulatory Affairs Manager

Regulatory Affairs manager - Medical Devices

Overview

Regulatory Affairs manager - Medical Devices. A new role in Regulatory Affairs has become available at an exciting medical devices organisation with products undergoing clinical trials. The role focuses on FDA and UK/EU submissions.

The candidate will manage and prepare regulatory submissions (e.g., variations, renewals, new market applications) and ensure compliance with U.S. (FDA) and European (EMA) regulations. Key responsibilities include strategic planning, cross-functional coordination with manufacturing, quality assurance, regulatory writing and document review, and liaising with health authorities. The head office is based in Oxfordshire.

Responsibilities

• Submission Strategy: Developing strategic plans for regulatory submissions, including variations, renewals, and new market applications.
• Document Preparation: Writing, reviewing, and ensuring the accuracy and compliance of submission documents, such as CMC data, study reports, and other regulatory materials.
• Regulatory Compliance: Ensuring all submissions and regulatory activities meet the requirements of the FDA (U.S.) and EMA (European).
• Cross-Functional Coordination: Collaborating with internal teams (manufacturing, quality assurance, quality control, etc.) and external partners to gather necessary information for submissions.
• Authority Interaction: Communicating with health authorities (e.g., FDA, EMA) regarding submissions, queries, and regulatory matters.
• Post-Approval Maintenance: Managing ongoing regulatory activities such as post-approval variations, annual reports, and changes to product manufacturing.

Required Skills & Qualifications

• Regulatory Knowledge: In-depth understanding of FDA and EU regulatory requirements for pharmaceutical products or medical devices.
• Technical Skills: Proficiency in regulatory document management systems and MS Office applications.
• Communication: Strong written and verbal communication skills in English.
• Project Management: Ability to manage multiple projects, meet deadlines, and prioritize tasks effectively.
• Collaboration: A collaborative team player with cultural awareness and adaptability.

We look forward to receiving your application. The facility is based in Oxfordshire and offers hybrid working opportunities.

CY Partners is acting as an Employment Business / Agency in relation to this vacancy.