Regulatory Partner

Description:

Are you looking for a role that makes you feel valued, important and offers you the opportunity to make meaningful and transformative positive impacts on people's lives?

We are working with a global client whose ethos is plain and simple: we come to work to help be a part of a better future. If you are looking for a role within a business that inspires self-motivation, commitment and passion then you may just be the perfect missing piece to their team in Welwyn.

Our client requires a Regulatory Partner They are committed to rewarding their employees for their impactful challenging work, so here are the perks:

Hybrid (2/3 days in office), providing flexibility when able
Free parking onsite
Fun company events
Personalised development and training opportunities
25 days holiday per annum + recognised bank holidays

You will be the kind of person who wants to make a difference within your day-to-day work, but of course there are a few other requirements:

Hold a scientific degree.
Must have medical device experience and 8 years of Biotech pharma experience
Strong regulatory knowledge and experience in the medical devices (and preferably pharmaceutical) industry to support foundation and squad work within a regulated environment.
Possess broad regulatory expertise to contribute to foundation and squad tasks, help develop squad/chapter plans and goals, and support the learning and development of other members.
Understand scientific and technical information related to company products.

In this role you will be working in and amongst the Regulatory group, translating the evolving UK regulatory requirements into company policies, procedures, solutions, and strategies to ensure compliance and maximise patient value. You will also be responsible for:

Ensure regulatory compliance for Clinical Trial Applications involving all types of Medical Devices (physical, digital, in-vitro diagnostics, etc.).
Monitor changes in UK Regulatory environment, assessing impacts on current frameworks or new regulations.
Participate in Trade Association working groups (e.g., ABHI, ABPI, MedTech) to gather regulatory intelligence.
Track and assess implementation of regulations relevant to medical devices, including sustainability/environmental regulations.
Support the implementation/adaptation of medical device structures within the UK Affiliate.
Provide regulatory advice to project teams to ensure compliance and timely market release.
Support external regulatory audits and provide input to minimize non-compliance findings.
Advise manufacturers/global teams on obtaining and maintaining UKCA marks and other relevant regulatory milestones.
Assist teams in interactions with MHRA concerning medical devices.
Train personnel on medical device regulations and related aspects.
Offer regulatory expertise for new product development.
Maintain regulatory files and tracking databases for prompt, accurate access to information.
Review product and process documentation for compliance, ensuring timely renewals.
Liaise between project teams to gather information and address queries.
Assess and provide impact assessments for changes to existing products and company practices.
Review marketing materials and advise commercial teams on business-related activities.

Location: Welwyn (Hybrid 2/3 days in office)

Salary: £367.54 - £452.36 per day (PAYE) OR £487.50 - £600 per day (UMB/LTD)

Full Time

12 month Contract Inside IR35

For more information about this Regulatory Partner role, please contact Chloe McCausland at Clearline Recruitment