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- Tasks: Join a dynamic team ensuring medical device safety and efficacy across global markets.
- Company: A Scottish medical device company expanding globally due to high demand.
- Benefits: Enjoy flexible working options, competitive salary, and bonus packages.
- Why this job: Gain valuable experience in regulatory affairs while contributing to impactful healthcare solutions.
- Qualifications: BSc in a technical field; experience in medical devices or diagnostics required.
- Other info: Hybrid work preferred for team collaboration and strategy planning.
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 experience with technical documentation and global regulatory filings. Being able to articulate your past successes and challenges will set you apart from other candidates.
✨Tip Number 4
Show enthusiasm for the company's mission and products during your interactions. Research their recent achievements, such as FDA approvals, and express how your skills align with their goals, particularly in maintaining product safety and efficacy.
We think you need these skills to ace Senior Regulatory Affairs Associate
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Regulatory Affairs Associate position. Familiarize yourself with the specific regulatory areas mentioned in the job description, such as FDA approval processes and EU legislation.
Tailor Your CV: Customize your CV to highlight your relevant experience in regulatory affairs, particularly within medical devices. Emphasize your knowledge of MDR, PMA applications, and any global regulatory filings you've 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 your experience with technical documentation and how it aligns with the company's goals.
Highlight Team Collaboration Skills: Since the role emphasizes teamwork and collaboration, be sure to include examples of how you've successfully worked within a team in previous roles. This will demonstrate your ability to fit into their existing team dynamic.
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 provide examples from your past experiences. Discuss any challenges you faced and how you overcame them to ensure compliance.
✨Emphasize Team Collaboration
The company values teamwork, so share examples of how you've successfully collaborated with cross-functional teams in previous roles. Highlight your ability to act as a 'glue' within a team, which is crucial for this position.
✨Discuss Your Adaptability to Change
Given the dynamic nature of regulatory affairs, it's important to convey your adaptability to changing legislation and market demands. Share instances where you've had to quickly adjust your strategies or processes in response to new regulations.
