Assistant Regulatory Manager

JR United Kingdom; Stoke-on-Trent; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading company in Footcare is seeking an Assistant Regulatory Manager to support regulatory compliance and product registration across global markets. This role offers the opportunity to contribute to innovative product development while ensuring alignment with regional regulations and effective processes.

Qualifications

• At least 2 years of relevant regulatory experience.
• Experience with ISO 13485 and global registrations.
• Understanding of regional regulations impacting dossiers.

Responsibilities

• Support registration requirements for global product pipeline.
• Prepare and review regulatory documents for product registration.
• Provide regulatory training and support to teams.

Skills

Regulatory Compliance

Dossier Creation

Project Management

Quality Management Systems

Education

Honours degree in a scientific field

Job description

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Assistant Regulatory Manager, Stoke-on-Trent

Client:

Location:

Stoke-on-Trent, United Kingdom

Job Category:

Other

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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 in Footcare, with a portfolio that includes 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, oversee the rollout of existing products, and ensure regulatory compliance. They will work to support an integrated approach to regulatory planning across innovation, providing SME knowledge and the latest information on core dossier requirements relevant to the product portfolio.

The role involves ensuring that all regulatory activities are completed following best practices and consistent processes across projects.

Key Responsibilities:

• Support registration and regulatory requirements across multiple markets for a global pipeline.
• Define processes and procedures within the Global Regulatory Footcare team to optimize speed to market and streamline efficiency.
• Prepare and review regulatory documents for product registration in assigned markets.
• Maintain up-to-date knowledge of regional and national regulations, guidelines, and advisory documents.
• Participate in product development and marketing projects for local and international launches.
• Maintain and update regulatory databases with accurate product records.
• Provide regulatory training and support to teams.
• Contribute to regulatory strategies for successful product registration and variations globally.
• Develop knowledge and intelligence within the Regulatory Function to promote a 'right first time' approach.
• Collaborate with partner functions to meet market-specific data requirements and timelines.
• Build strong relationships with local regulatory contacts to facilitate aligned plans and shared learnings.

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 such as ISO 13485.
• Knowledge of regulatory classifications and legislation including Medical Devices, Cosmetics, General Products, REACH, or Biocides, or an interest to develop this knowledge.
• Understanding of regional and global regulatory environments and their impact on dossiers and registration.
• Experience in preparing submissions, variations, renewals, and technical updates.
• Knowledge of global product development practices, rules, regulations, and guidelines.
• Awareness of factors influencing the regulatory environment, including emerging guidelines.
• Ability to deliver consistently and independently to deadlines, budget, and quality standards in high-pressure environments.