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For Companies At a Glance
- Tasks: Assist in global regulatory approvals and maintain compliance for medical devices.
- Company: Join Advanced Medical Solutions, a leader in innovative tissue-healing technology with a global presence.
- Benefits: Enjoy a diverse workplace, opportunities for growth, and a chance to make a real impact.
- Why this job: Be part of a dynamic team that values innovation and quality outcomes for patients worldwide.
- Qualifications: A science-based degree or relevant experience in the medical device field is required.
- Other info: This role offers a unique opportunity to interface with various departments and regulatory authorities.
The predicted salary is between 30000 - 42000 £ per year.
Overview
Vacancy Name: Regulatory Affairs Assistant
About Advanced Medical Solutions
When we say we\’re a world leading independent developer and manufacturer of innovative and technologically advanced products for the global advanced wound care, wound closure and surgical markets, we\’re not joking. We\’re much more than that. With over 700 employees across the globe, we pride ourselves on creating an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the right environment to foster innovation, growth and meaningful work. We are highly dependent on the creativity of our employees for our future growth and success. Our motto \’Care, Fair, Dare\’ summarises our culture and defines the principles of how we operate as one team to achieve success. AMS provides equal employment opportunities for all applicants. We value and encourage diversity across our workforce, meaning that no one will be discriminated against because of gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.
Job Details
- Submit and maintain global regulatory approvals on behalf of AMS Group to meet the requirements of the business plan.
- To support regulatory submissions for new markets and maintaining registrations and licences in existing markets.
- To support customer audit requests, tender requests and all general requests associated with International Registrations.
Key responsibilities
- Compile and submit regulatory submissions for approval in applicable markets.
- Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical device framework in the countries registered.
- Supporting and advising other functions within the business for information and registration requests.
- Coordinate the preparation, review and submit timely responses to requests for additional information from regulatory authorities on product registrations.
- Support customer market registration activities, within the terms of existing contractual obligations.
- Participate in and support audits/reviews by regulatory authorities and customers in regards to the International Registrations system including preparation, facilitation and response.
- Monitor relevant industry-wide International Registration activities.
- Continuous improvement and development of the international registrations process.
- Promote and demonstrate Care, Fair and Dare values in the workplace.
- Promote health and safety policies in the workplace.
- The role is a key role within the business, interfacing with customers, in-country agents, regulatory authorities, Quality, Marketing, R&D, and Clinical on a regular basis.
- Implements the International Registrations system for the AMS Group.
- Due to the nature of the role the individual must be able to deliver to critical deadlines and manage workload and time effectively, whilst meeting enforced regulatory timelines.
What we\’re looking for
- Science based degree (or equivalent), or relevant experience of working in the medical device field, preferably in a regulatory role.
- Ideally has experience in key market approval requirements within APAC, EMEA and LATAM Regions.
- Excellent communication skills both written and verbal with employees, customers, in country agents and Regulatory Authorities.
- Competent IT skills.
- The ability to influence and challenge others in a constructive way to deliver improvements.
Employment Basis
Full Time
Location
Location Country: United Kingdom
Location City: Plymouth
Applications Close Date
14 Nov 2025
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Regulatory Affairs Assistant employer: Advanced Medical Solutions
Contact Detail:
Advanced Medical Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Assistant
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks in the APAC, EMEA, and LATAM regions. Understanding the nuances of these markets will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with medical devices. Engaging with industry groups or attending relevant webinars can provide insights and connections that may benefit your application.
✨Tip Number 3
Stay updated on the latest trends and changes in medical device regulations. This knowledge can be a great conversation starter during interviews and shows that you are proactive about your professional development.
✨Tip Number 4
Prepare to discuss how you would handle tight deadlines and manage multiple regulatory submissions. Providing examples from past experiences can illustrate your ability to thrive in a fast-paced environment, which is crucial for this role.
We think you need these skills to ace Regulatory Affairs Assistant
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Regulatory Affairs Assistant position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise any relevant experience you have in regulatory affairs or the medical device field. Mention specific projects or roles where you managed regulatory submissions or compliance.
Showcase Communication Skills: Since excellent communication skills are crucial for this role, provide examples in your application that demonstrate your ability to communicate effectively with various stakeholders, including regulatory authorities and internal teams.
Tailor Your Cover Letter: Craft a personalised cover letter that reflects your understanding of AMS's values and how your background aligns with their mission. Mention your enthusiasm for contributing to their innovative tissue-healing technology.
How to prepare for a job interview at Advanced Medical Solutions
✨Know Your Regulatory Frameworks
Familiarise yourself with the regulatory requirements specific to the medical device industry, especially in the APAC, EMEA, and LATAM regions. Being able to discuss these frameworks confidently will show your understanding of the role.
✨Demonstrate Strong Communication Skills
Prepare to showcase your communication abilities, both written and verbal. You might be asked to explain complex regulatory concepts, so practice articulating your thoughts clearly and concisely.
✨Highlight Relevant Experience
Be ready to discuss any previous experience you have in regulatory affairs or related fields. Use specific examples to illustrate how you've successfully navigated regulatory submissions or maintained compliance in past roles.
✨Showcase Your Problem-Solving Skills
Expect questions that assess your ability to handle challenges in regulatory processes. Prepare examples of how you've approached problems in the past, particularly in meeting critical deadlines or managing multiple tasks effectively.
