Social network you want to login/join with:
Assistant Regulatory Manager, Warrington, Cheshire
Client:
Location:
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. They have a portfolio across medical devices, cosmetics, orthotics, and personal care, and are looking to add an Assistant Regulatory Manager to their team.
The Assistant Manager will support the delivery of NPD/EPDs to global markets, the rollout of existing products, and maintaining product compliance. You will work to support regulatory planning across innovation and provide SME knowledge on core dossier requirements.
You will ensure all regulatory activities are completed efficiently and consistently across projects.
The Role
* Support registration and regulatory requirements across multiple markets to deliver a global pipeline.
* Define processes within the Global Regulatory Footcare team to optimize speed to market.
* Prepare and review regulatory documents for product registration.
* Stay 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 records.
* Provide regulatory training and support to teams.
* Develop regulatory strategies for successful product registration and variations.
* Enhance knowledge within the Regulatory Function for a 'right first time' approach.
* Collaborate with partner functions on data requirements and timelines.
* Build relationships with local regulatory contacts and partner functions to facilitate efficient market entry.
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 global regulatory environments impacting dossiers and registrations.
* Experience preparing submissions, variations, and renewals.
* Knowledge of product development regulations and guidelines.
* Awareness of factors influencing the regulatory environment, including emerging guidelines.
* Ability to deliver work independently within time, cost, and quality standards in high-pressure settings.
#J-18808-Ljbffr