Regulatory Affairs manager – Medical Devices
A new role in Regulatory Affairs has become available at an exciting medical devices organisation who have products undergoing clinical trials. The role focuses on FDA and UK/EU submissions
As an experienced Regulatory Affairs professional, you’ll 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 company has exciting medical device products currently undergoing clinical trials. Head office is based in Oxfordshire.
Key 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 Chemistry, Manufacturing, and Controls (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 European Medicines Agency (EMA).
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.
This is an exciting opportunity at a growing medical devices organisation. The facility is based in Oxfordshire and offers hybrid working opportunities.
We look forward to receiving your application.
CY Partners is acting as an Employment Business / Agency in relation to this vacancy