Senior Manager Regulatory Affairs
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Location | South East |
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Job Type | Permanent |
Senior Regulatory Manager Main Responsibilities: As the Senior Regulatory Manager, you will line manage the Regulatory Assistant and collaborate with the wider team, particularly with R&D, clinical, and commercial teams. Your responsibilities will include: Leading and delivering input to new product development projects, including: Contributing to regulatory strategy and planning to achieve project/program goals…
Responsibilities
Senior Regulatory Manager
Main Responsibilities:
As the Senior Regulatory Manager, you will line manage the Regulatory Assistant and collaborate with the wider team, particularly with R&D, clinical, and commercial teams. Your responsibilities will include:
- Leading and delivering input to new product development projects, including:
- Contributing to regulatory strategy and planning to achieve project/program goals and gather regulatory requirements
- Working with the Clinical Study Manager to set up, initiate, and monitor analytical and clinical verification and validation studies at third-party sites, including obtaining appropriate ethics clearances, permissions, and developing SOPs for study conduct
- Managing and delivering post-market surveillance activities for IVD products to meet regulatory requirements in registered territories
- Liaising with regulatory authorities and notified bodies and creating device registration submissions with in-territory advisors/distributors to support global commercial rollout.
This includes preparing materials such as:
- Labelling documents
- Maintaining the regulatory department budget and representing the regulatory function in internal and external audits
- Reviewing product promotional material and all external content for regulatory compliance
- Proactively contributing to and monitoring the content of individual Design History Files to support New Product Development (NPD) procedures and regulatory requirements
- Supporting and actively promoting the ISO 13485 quality system through accurate working in accordance with procedures, including developing new procedures as needed
Required experience to be considered:
- Essential experience in medical device product development adhering to standards such as ISO 14971
- Previous experience in a similar regulatory role within the medical devices sector is essential
- Proven track record of developing regulatory pathways and securing approvals worldwide
- Excellent knowledge of global medical device directives and regulations, MEDDEV guidelines, ISO standards, and US FDA and worldwide regulatory requirements
- Highly detail-oriented with a commitment to high-quality data
- Ability to work on multiple projects simultaneously