Assistant Regulatory Manager

Mackinnon Bruce International; Hull and East Yorkshire; On-site; GBP 40,000 - 60,000; Full time

Job summary

Mackinnon Bruce International is seeking an Assistant Regulatory Manager to support the delivery of new and existing products globally within the footcare sector. The ideal candidate will manage regulatory compliance processes, contribute to product development, and collaborate with global teams to optimize market access. This role requires strong knowledge of regulatory frameworks and at least two years of relevant experience in regulatory affairs, making it a pivotal position for ensuring the successful registration of products in diverse international markets.

Qualifications

• At least 2 years of relevant regulatory experience.
• Experience with quality management systems (ISO 13485).
• Familiarity with Medical Devices and Cosmetics regulations.

Responsibilities

• Support registration requirements across multiple markets.
• Prepare and review regulatory documents for products.
• Maintain updated knowledge of relevant regulations.

Skills

Regulatory experience

Knowledge of dossier creation

Understanding of global regulations

Ability to deliver under pressure

Education

Honours degree in a scientific field

Job description

3 days ago Be among the first 25 applicants

Mackinnon Bruce International provided pay range

This range is provided by Mackinnon Bruce International. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Direct message the job poster from Mackinnon Bruce International

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.
• Maintains 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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Project Management, and Research

• Industries

  Medical Equipment Manufacturing and Chemical Manufacturing

Referrals increase your chances of interviewing at Mackinnon Bruce International by 2x

Get notified about new Regulatory Manager jobs in City Of Kingston Upon Hull, England, United Kingdom.

Regulatory Operations Manager, Essential Home

Kingston Upon Hull, England, United Kingdom 1 week ago

Senior Manager, Global Compliance and Performance

Kingston Upon Hull, England, United Kingdom 5 days ago

R&D Manager - Regulatory Business Process Lead

Kingston Upon Hull, England, United Kingdom 5 days ago

Kingston Upon Hull, England, United Kingdom 1 week ago

Senior Lab Technician (Analytical Chemist)

Kingston Upon Hull, England, United Kingdom 1 week ago

Kingston Upon Hull, England, United Kingdom 6 days ago

Kingston Upon Hull, England, United Kingdom 1 month ago

Kingston Upon Hull, England, United Kingdom 5 days ago

Kingston Upon Hull, England, United Kingdom 2 weeks ago

R&D Associate Liquid Electrical (LE) Devices, Essential Home

Kingston Upon Hull, England, United Kingdom 1 week ago

Kingston Upon Hull, England, United Kingdom 6 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.