Clinical Regulatory Lead

Milton Keynes, Buckinghamshire
Competitive salary DOE
25 Apr 2019
23 May 2019
Contract Type
Full Time

Clinical Regulatory Lead
Home Based or Office Based (working from UK, Netherlands, France, Germany, Italy or Spain offices) 

About Us 

We’re BSI, the business standards company that helps organizations all over the world make excellence a habit. For more than a century, we’ve been showing businesses how to improve performance, reduce risk and achieve sustainable growth. 

When it comes to medical devices, our mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications. 

We’re currently looking for a Clinical Regulatory Lead to join us and support the delivery of our medical device certification solutions.

The Benefits 

- Competitive salary DOE
- Excellent company-contributed pension scheme 
- Flexitime 
- Company-paid private medical insurance     
- A wide range of flexible benefits that you can tailor to suit your lifestyle     
- Develop your career with a business that’s committed to continual improvement, integrity and inclusivity     
- 27 days’ annual leave (with the opportunity to increase this to 30 days)   

This is a fantastic opportunity to step into an exciting leadership role and help uphold the high standards of a leading regulatory body. 

You will have the chance to play a vital role in the creation of our clinical compliance strategy and impact how our organization operates on a global scale.  

So, if you think you could make a difference with an organization that’s been helping businesses perform at their best for over a century, we want to hear from you. 

The Role

As the Regulatory Clinical Lead, you’ll help to ensure that we deliver our medical device certification solutions in-line with relevant clinical regulations. You’ll also become a key player in the development of our clinical compliance strategy. 

In this important role, you’ll provide insight into clinical regulations to support our medical devices strategy, policies, procedures and documentation, ensuring we meet notified body designation requirements. 

Additionally, you’ll: 

- Support the Head of Compliance in leading the processes for clinical evaluation and post-market requirements
- Provide expertise and guidance on medical devices and CE marking 
- Assist colleagues with certification recommendations, technical documentation reviews and audits 
- Occasionally travel internationally to deliver internal training 

About You 

To join us as the Regulatory Clinical Lead, you’ll need: 

- Audit experience and/or an understanding of how to create, facilitate and maintain clear audit trails 
- A good understanding of medical devices regulations and related guidance and standards
- Knowledge of clinical evaluation processes, data analysis and clinical study design 
- Logic and evidence-based analytical skills 
- A degree (or equivalent) in medicine, nursing, biomedical sciences, biostatistics or a related discipline 

Other companies may call this role Head of Clinical Regulations, Senior Audit Manager, Senior Regulatory Clinical Manager, Senior Clinical Regulations Manager, Senior Clinical Compliance Manager or Medical Device Regulatory Manager. 

Webrecruit and BSI are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.    

So, if you are looking to make your mark as a Regulatory Clinical Lead, please apply via the button shown. This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency.