Assistant Regulatory Manager (, , United Kingdom)

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 product and maintenance of product 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 a complex and diverse set of registration/regulatory requirements across multiple markets to enable the strategic delivery of a global pipeline.
• Work within the Global Regulatory Footcare team to define processes and procedures to optimise speed to market and streamline efficiencies.
• Prepare and review regulatory documents for the registration of current and new products 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/or 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 the development of regulatory strategies to enable successful registration & variations to products in global markets.
• Maintain and develop knowledge and intelligence across the Regulatory Function to build ‘right first time’ approach with respect to registrations globally.
• Collaborate with partner functions to agree market specific data requirements and delivery timelines.
• Develop excellent working relationships with local (regional) regulatory contacts to facilitate aligned regulatory plans and shared learnings to ensure efficient speed to market.
• Create strong and proactive relationships with all partner functions.

The Requirements

• Educated to honours degree level in a scientific field or equivalent experience.
• Relevant Regulatory experience and knowledge in dossier / technical file creation and global registrations (at least 2 years).
• Experience working with quality management systems and standards (ISO 13485).
• Experience in different regulatory classifications and/or legislation including Medical Devices, Cosmetics, General Product, REACH or Biocide, or interest to develop their knowledge of.
• Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registration.
• Experience in preparing and submitting dossiers, variations, renewals and technical file updates.
• Understanding of global product development practice, rules, regulations and guidelines.
• Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.
• Ability to consistently & independently deliver to time, cost and quality standards in a high-pressure environment.