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Assistant Regulatory Manager, Stoke-on-Trent
Client:
Location:
Stoke-on-Trent, 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 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.
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