Regulatory Manager

Salary: £60,000 – £72,000 per year

– REMOTE POSITION –

Adecco is working closely with a Medical Device manufacturer, looking for either a Senior Regulatory Specialist or Regulatory Manager to join the team on a permanent basis.

This position will see you responsible for ensuring that all new and existing products & services are compliant with relevant regulatory authorities, you will also play a huge part in supporting commercial activities in target markets.

There are some big projects on the horizon which include the following:

– Achieving UKCA mark for class iib products
– Leading the company through MDD to MDR transition, remediating technical documentation to ensure compliance
– Expanding market presence, focusing on new product submissions
– Strengthening the company’s market share in US and EU, whilst entering new markets such as the Middle East
– Work closely with; sales, commercial operations, finance, IT, engineering, production, NPD, regulatory and QA to ensure site-wide compliance and consistency throughout teams

Given the scope of the work, to be considered the company asks for the following experience:

• 5 years’ regulatory experience in medical device design & manufacture (minimum Class II)
• Experience of working in a manufacturing environment
• Conversant with EU, APAC and US, and other global regulations
• Demonstrated experience in submitting medical device applications to notified bodies
• A clear understanding of constructing technical files for Class ii products.
• Financial or budgetary management experience

Although this position is predominantly remote, there will be occasional travel to the sites across the UK.

So, what’s in it for you?

• Car allowance of £500 per month
• 20% bonus linked to company performance
• 25 days holidays per annum
• Company pension of 4%
• Death in Service from day 1 of employment 2 times your annual salary
• Medicash health plan
• Individual BUPA cover

If you have the relevant experience and are interested to learn more, please apply with an up to date CV.

Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.