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- Tasks: Support global product registrations and ensure compliance with regulatory standards.
- Company: Join a leading company in the Footcare industry focused on innovation and quality.
- Benefits: Enjoy flexible working options, professional development opportunities, and a collaborative culture.
- Why this job: Be part of a dynamic team driving product launches that make a real impact globally.
- Qualifications: Honours degree in a scientific field and relevant regulatory experience required.
- Other info: Opportunity to work with diverse markets and develop strong professional relationships.
The predicted salary is between 36000 - 60000 £ per year.
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 will ensure that all regulatory activities are completed according to the best process, in a consistent approach across projects.
Key responsibilities
- 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 optimize 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.
Key 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.
- 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.
- Ability to consistently & independently deliver to time, cost and quality standards in a high-pressure environment.
Regulatory Affairs Assistant Manager employer: Mackinnon Bruce International
Contact Detail:
Mackinnon Bruce International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Assistant Manager
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements for the markets you're interested in. Understanding the nuances of different regions can give you an edge in discussions and demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with global registrations. Attend industry events or join relevant online forums to build connections that could help you learn more about the role and the company.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory guidelines, particularly those related to medical devices and cosmetics. This knowledge will not only prepare you for interviews but also show your proactive approach to staying informed.
✨Tip Number 4
Prepare to discuss your experience with quality management systems and how they relate to regulatory compliance. Be ready to provide examples of how you've successfully navigated complex regulatory environments in past roles.
We think you need these skills to ace Regulatory Affairs Assistant Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in dossier creation and global registrations. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about regulatory affairs and how your background aligns with the responsibilities outlined in the job description. Mention specific experiences that showcase your ability to manage regulatory processes effectively.
Showcase Relevant Skills: Emphasise your knowledge of regional and global regulations, as well as your experience with quality management systems like ISO 13485. Provide examples of how you've successfully navigated complex regulatory environments in previous roles.
Highlight Collaborative Experience: Since the role involves collaboration with various teams, include examples of how you've built strong working relationships in past positions. This could involve cross-functional projects or training sessions you've led on regulatory practices.
How to prepare for a job interview at Mackinnon Bruce International
✨Know Your Regulations
Make sure you brush up on the latest regional and global regulations related to medical devices, cosmetics, and other relevant classifications. Being able to discuss specific regulations and how they impact product registration will show your expertise and readiness for the role.
✨Demonstrate Process Knowledge
Be prepared to talk about your experience with dossier creation and regulatory submissions. Highlight any specific processes you've optimised in previous roles, as this will demonstrate your ability to streamline efficiencies in the regulatory landscape.
✨Showcase Collaboration Skills
Since the role involves working closely with various teams, be ready to share examples of how you've successfully collaborated with cross-functional teams in the past. Emphasise your ability to build strong relationships and communicate effectively with different stakeholders.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in high-pressure situations. Think of scenarios where you had to deliver under tight deadlines or manage conflicting priorities, and be ready to explain how you handled them while maintaining quality standards.
