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- Tasks: Join a dynamic team ensuring product safety and efficacy in global markets.
- Company: A Scottish medical device company expanding globally due to high demand.
- Benefits: Enjoy flexible working, competitive salary, and bonus opportunities.
- Why this job: Gain valuable experience in regulatory affairs while contributing to impactful healthcare solutions.
- Qualifications: BSc in a technical field with experience in medical devices or diagnostics required.
- Other info: Remote work is available, but hybrid work is preferred for team collaboration.
The predicted salary is between 36000 - 60000 £ per year.
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Direct message the job poster from Entrust Resource Solutions
Finding Outstanding Talent in the Emerging Scientific Industry
Regulatory Affairs Team Lead
IVD
Edinburgh
I am very pleased to be able to offer this role with one of our established clients. With a global presence and several large sites, this is a great opportunity to take your regulatory experience global and work within the UK, EU, APAC and US markets! They recently received impressive funding for a new product and are taking over the cutting edge diagnostics space.
This role will be leading a small team across new products and continuing surveillance for one of their most successful product portfolios.
Key Requirements:
- UK, EU and US regulatory submission experience is ideal but we can consider individual merit
- Experience leading 510(k) submissions would be ideal
- Experience in CE marking, PMS activities for global diagnostics
- A people orientated personality / previous team lead experience
Why Apply?
- No doubt the diagnostics world has been shaken after the COVID-19 situation, but on offer is a stable position, with a business who have been operating for 17 years. They now have over 300 employees across multiple sites and a successful product portfolio.
- A flexible working model, hybrid in one of the UK\’s best cities!
- What the team describe as a positive, supportive culture with on-site facilities, regular social incentives if you want to partake, and health and wellbeing initiatives.
Apply now by hitting \’easy apply\’ or emailing dion@entrustrs.com
Seniority level
-
Seniority level
Associate
Employment type
-
Employment type
Full-time
Job function
-
Job function
Writing/Editing and Quality Assurance
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Industries
Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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Entrust Resource Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate
✨Tip Number 1
Make sure to research the company thoroughly. Understand their products, recent achievements, and future goals. This knowledge will help you tailor your conversations and show genuine interest during any discussions.
✨Tip Number 2
Network with current or former employees of the company on platforms like LinkedIn. They can provide insights into the company culture and the specifics of the role, which can be invaluable when preparing for interviews.
✨Tip Number 3
Stay updated on the latest changes in EU legislation and global regulatory requirements. Being knowledgeable about current trends will not only boost your confidence but also demonstrate your commitment to the field during discussions.
✨Tip Number 4
Prepare specific examples from your past experience that highlight your skills in regulatory affairs, especially related to medical devices. Be ready to discuss how you've successfully navigated regulatory challenges in previous roles.
We think you need these skills to ace Senior Regulatory Affairs Associate
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description. Understand the key responsibilities and required skills for the Senior Regulatory Affairs Associate position, especially the importance of knowledge in EU legislation and experience with medical devices.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory affairs, particularly in medical devices. Emphasise your familiarity with 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 company's mission. Mention specific experiences that align with their needs, such as preparing technical documentation or developing regulatory strategies.
Highlight Team Collaboration Skills: Since the role involves working closely with a team, be sure to mention your ability to collaborate effectively. Provide examples of how you've contributed to team success in previous roles, especially in high-stakes environments.
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 explain your experience in these areas. Bring examples of past submissions or strategies you've developed to showcase your skills.
✨Emphasise Team Collaboration
Given that the Regulatory Affairs Team is described as the 'glue of the business', it's important to convey your ability to work well in a team. Share experiences where you successfully collaborated with others to achieve regulatory goals.
✨Discuss Adaptability to Changing Regulations
With the ever-evolving nature of regulatory requirements, be prepared to discuss how you've adapted to changes in legislation in the past. This will show your potential employer that you can navigate the complexities of the regulatory landscape effectively.
