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Let's push the boundaries together and make the most of your talents!

Head of Device Vigilance - UK, EU, SWZ or US

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Drug Safety & Pharmacovigilance
Job ID:  69489

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

To strengthen our Patient Safety and Medical Management (PSMM) department, we are looking for a talented individual to fill the position of: Head of Device Vigilance. This role can be based in the UK, EU, Switzerland or the US.

As a Head of Device Vigilance, you will provide safety device expertise and leadership to PSMM for all UCB Medical Devices, including Software as Medical Device (SaMD), wearable sensors, digital Biomarkers, non-regulated and regulated investigational devices, class I-III medical devices, drug delivery devices, and in vitro diagnostics.

 

You like to work in an environment where you will: 
•    Be part of the PSMM leadership team, reporting directly to the head of PSMM
•    Develop and lead a global team to support Device Vigilance requirements and processes for UCB’s device portfolio
•    Be accountable for device safety strategy leadership/support for MD activities in all regions (including but not limited to: US, EU, CA, JP, China, Latin America) 
•    Be part of the UCB device working group and build a strong external network 

 

To contribute, you will: 
•    Develop and lead a global team to deliver Device Vigilance requirements and processes for UCB’s device portfolio (Class I-III devices, wearables, Software as Medical Devices, Drug Delivery Devices, IVD)
•    Develop and maintain a compliant medical device vigilance system
•    Be the primary subject matter expert and point of contact for Device Vigilance during relevant Health Authority inspections and both announced and unannounced Notified Body audits
•    Drive and manage resource allocation to expand the already existing Device QMS (ISO 13485:2016) 
•    Review, respond and implement corrective and preventative actions with respect to medical device vigilance and post-marketing surveillance (PMS) from audit and inspection findings
•    Represent Patient Safety as a Device Vigilance SME organizationally and during governance activities required for successful operation of processes across multiple divisions, functions, sites and diverse cultures globally
•    Generate concepts, define strategies and actively implement medical device PMS and Vigilance standards within Patient Safety as a medical device vigilance expert
•    Manage and contribute to the post-marketing surveillance program activities 

 

Interested? For this position you’ll need the following education, experience and skills: 
•    At least 10 years of device vigilance experience preferably with a device company or notified body
•    Experience in building and leading a global team
•    Expert understanding and application of medical device regulations and industry standards globally for design control, device risk management, and post-market surveillance throughout the device lifecycle (e.g. 21 CFR Parts 803, 806, and 820, 822, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and European Union Medical Device Regulation 2017/745)
•    Has thorough knowledge of not only pharmacovigilance theory, regulations, and application but also has knowledge of safety technology systems and how pharmacovigilance fits into the larger scope of the drug development cycle
•    Champions change

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

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