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- Tasks: Join a dynamic team ensuring the safety and efficacy of medical devices globally.
- Company: A Scottish medical device company expanding internationally due to high demand.
- Benefits: Enjoy flexible working options, competitive salary, and bonus packages.
- Why this job: Gain exposure to global markets while working with top professionals in regulatory affairs.
- Qualifications: BSc in a technical/scientific field; experience in medical devices or diagnostics required.
- Other info: Hybrid work preferred; individual circumstances considered for remote work.
The predicted salary is between 43200 - 72000 £ per year.
Senior Regulatory Affairs Associate Medical Device West Lothian ~ remote working available but hybrid preferred After an incredible 12 months of working towards FDA approval and opening overseas manufacturing sites, this Scottish born medical device company are going global due to demand for their product. As part of their growth, they are searching for an experienced regulatory professional with relevant medical device or similar experience. This role offers exposure to several regulatory areas. You will be working across global markets (US, UK, EU), and knowledge of changing EU legislation will be highly valuable. Their Regulatory Affairs Team underpin the whole business. As manufacturers of a high risk device, it is imperative that the safety and efficacy of the product is maintained. You will be joining an existing team of excellent professionals who truly act as the glue of the business! For this reason, whilst remote working is available, some time on-site is preferred for road mapping, strategy planning and team bonding. We are happy to consider individual circumstances when discussing this. Some preferrable areas of experience: Preparation of technical documentation and submission of global regulatory filings Familiar with MDR, PMA applications and supplements Regulatory strategies for new products Requirements: BSc level in a technical or scientific discipline Experience within medical devices or diagnostics Knowledge of EU and international regulatory requirements Why Apply? A flexible working environment A strong salary and bonus package The chance to gain or continue your career exposure to global markets and advance your experience! How to apply: Hit the ‘Easy Apply’ button on this post, or email dion@entrustrs.com for a private discussion.
Senior Regulatory Affairs Associate employer: Entrust Resource Solutions
Contact Detail:
Entrust Resource Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate
✨Tip Number 1
Familiarize yourself with the latest EU regulations and guidelines related to medical devices. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly changing field.
✨Tip Number 2
Network with professionals in the regulatory affairs space, especially those who have experience with medical devices. Engaging with industry groups or attending relevant webinars can provide valuable insights and connections that may lead to job opportunities.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with regulatory submissions and technical documentation. Highlighting your hands-on experience will show that you are well-equipped for the responsibilities of this role.
✨Tip Number 4
Emphasize your ability to work collaboratively within a team, especially in a hybrid working environment. Share examples of how you've successfully contributed to team projects in the past, as this role values teamwork highly.
We think you need these skills to ace Senior Regulatory Affairs Associate
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Regulatory Affairs Associate position. Highlight the key responsibilities and required experiences, such as knowledge of EU legislation and experience with medical devices.
Tailor Your CV: Customize your CV to reflect your relevant experience in regulatory affairs, particularly in medical devices. Emphasize your familiarity with MDR and PMA applications, as well as any global regulatory filings you have managed.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the medical device industry. Mention specific examples of your past work that align with the responsibilities of the role.
Highlight Team Collaboration Skills: Since the role emphasizes teamwork and collaboration, be sure to include examples in your application that demonstrate your ability to work effectively within a team, especially in a hybrid or remote setting.
How to prepare for a job interview at Entrust Resource Solutions
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of EU and international regulatory requirements, especially regarding medical devices. Be prepared to discuss specific regulations like MDR and PMA applications, as this will demonstrate your expertise in the field.
✨Prepare for Technical Documentation Questions
Since the role involves preparation of technical documentation and global regulatory filings, be ready to discuss your experience in these areas. Bring examples of past submissions or strategies you've developed to showcase your skills.
✨Emphasize Team Collaboration
Given that the Regulatory Affairs Team is described as the 'glue of the business', emphasize your ability to work collaboratively. Share examples of how you've successfully worked with cross-functional teams to achieve regulatory goals.
✨Discuss Adaptability to Changing Regulations
With the fast-paced nature of regulatory affairs, it's crucial to show that you can adapt to changing legislation. Prepare to discuss how you've navigated changes in regulations in the past and how you stay updated on industry trends.
