Assistant Regulatory Manager

JR United Kingdom; High Wycombe; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading company in the Footcare industry is seeking an Assistant Regulatory Manager in High Wycombe. This role involves ensuring regulatory compliance for new and existing products and supporting regulatory planning across global markets. The ideal candidate will have a scientific degree, relevant experience in regulatory processes, and strong knowledge of quality management systems.

Qualifications

• Minimum 2 years of relevant regulatory experience.
• Experience with dossier/technical file creation.
• Knowledge of regulatory classifications and legislation.

Responsibilities

• Support registration and regulatory requirements for global products.
• Prepare and review regulatory documents for product registration.
• Develop regulatory strategies for successful product registration.

Skills

Regulatory compliance

Project management

Regulatory strategy development

Education

Honours degree in a scientific field

Tools

Quality management systems (ISO 13485)

Job description

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Assistant Regulatory Manager, High Wycombe

Location: High Wycombe, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 1

Posted: 04.06.2025

Expiry Date: 19.07.2025

Job Description:

Our client is a global leader within Footcare globally. They have a portfolio across medical devices, cosmetics, orthotics, and personal care. They are looking to add an Assistant Regulatory Manager to their team.

The Assistant Regulatory Manager will support the delivery of NPD/EPDs to global markets, manage existing products, and ensure regulatory compliance. They will support regulatory planning across innovation and provide SME knowledge on core dossier requirements.

The role involves ensuring regulatory activities are completed efficiently and consistently across projects.

The Role

• Support registration and regulatory requirements across multiple markets for a global product pipeline.
• Define processes within the Global Regulatory Footcare team to optimize speed to market.
• Prepare and review regulatory documents for product registration.
• Keep updated on regional and national regulations and guidelines.
• Participate in product development and marketing projects for local and international launches.
• Maintain regulatory databases with accurate product records.
• Provide regulatory training and support to teams.
• Develop regulatory strategies for successful product registration and variations globally.
• Build knowledge and intelligence within the Regulatory Function for a 'right first time' approach.
• Collaborate with partner functions on data requirements and timelines.
• Develop relationships with local regulatory contacts for aligned regulatory plans.

The Requirements

• Honours degree in a scientific field or equivalent experience.
• At least 2 years of relevant regulatory experience, including dossier/technical file creation and global registrations.
• Experience with quality management systems like ISO 13485.
• Knowledge of regulatory classifications and legislation, including Medical Devices, Cosmetics, REACH, or Biocides.
• Understanding of regional and global regulatory environments.
• Experience in preparing dossiers, variations, renewals, and updates.
• Knowledge of global product development practices and guidelines.
• Awareness of emerging regulatory guidelines.
• Ability to deliver work independently and on time in high-pressure environments.