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Assistant Regulatory Manager, Gloucester
Client:
Location: Gloucester, 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. With a portfolio across medical devices, cosmetics, orthotics, and personal care, they are looking to add an Assistant Regulatory Manager to the business.
The Assistant Manager will enable delivery of NPD/EPDs to global markets, rollout of existing products, and maintenance of products on the market to ensure regulatory compliance. You’ll work to support an integrated approach to regulatory planning across innovation and will provide SME knowledge and the latest information on core dossier requirements relevant to the product portfolio.
You will ensure that all regulatory activities are completed according to the best process, in a consistent approach across projects.
The Role
* Support registration/regulatory requirements across multiple markets to enable strategic delivery of a global pipeline.
* Define processes and procedures within the Global Regulatory Footcare team to optimize speed to market and streamline efficiencies.
* Prepare and review regulatory documents for current and new product registration in assigned markets.
* Maintain up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing.
* Participate in product development and marketing/sales projects aiming to launch products locally and internationally.
* Maintain and update internal regulatory databases ensuring accurate records for products.
* Provide training and support to teams on regulatory practices.
* Contribute to regulatory strategies for successful registration and variations in global markets.
* Build knowledge and intelligence across the Regulatory Function to promote a ‘right first time’ approach globally.
* Collaborate with partner functions to align market-specific data requirements and delivery timelines.
* Develop strong relationships with local regulatory contacts to facilitate aligned regulatory plans and shared learnings for efficient speed to market.
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 and standards (ISO 13485).
* Knowledge of different regulatory classifications and legislation including Medical Devices, Cosmetics, General Product, REACH, or Biocide, with interest to develop knowledge in these areas.
* Understanding of regional and global regulatory environments and their impact on dossiers and registration.
* Experience preparing and submitting dossiers, variations, renewals, and technical file updates.
* Knowledge of global product development practices, rules, regulations, and guidelines.
* Familiarity with factors influencing the regulatory environment, including emerging guidelines.
* Ability to deliver consistently and independently to time, cost, and quality standards in high-pressure environments.
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