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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.
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