At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Dir Med Device Safety 

The Director of Medical Device Safety will actively manage strategic and organizational activities required for successful operation of medical device safety along the product´s lifecycle. The incumbent will provide expert input and contributions on medical device topics during new product development (NPD), post-marketing surveillance (PMS) and risk management activities, Health Authority and Notified Body interactions, inspections and audits.

Your tasks and responsibilities 

 • Generate concepts , define strategies and actively implements medical device safety standards within the organization, as a medical device expert serving Bayer´s cross-divisional medical device portfolio globally

 • Manage and provide content contributions to the medical device safety and quality management systems including reporting to health authorities worldwide

• Manage and contribute to the PMS program activities including,  analysis and written contributions for the management of PMS Trending and any regulatory required aggregate reports 

• Provide NPD contributions to design control for medical devices throughout the development process and benefit-risk assessments. Represent Medical Device Safety in cross-functional projects and development teams.

Review study protocols and assess strategic and operational device requirements in clinical trials

• Interpret global regulations for execution and recommends modification to global device safety processes to ensure continued compliance and state of the art industry conformity.

 • Represent Medical Device Safety during announced and unannounced Health Authority inspections and Notified Body audits; review, and implements corrective and preventative actions from audit and inspection findings

 • Represent Medical Device Safety organizationally and during governance activities across multiple divisions, functions, sites and diverse cultures globally 

Who you are 

 • Master's Degree in Engineering or Life-science Discipline with professional medical device industry experience OR Bachelor's Degree in Engineering or Life-science Discipline with professional medical device industry experience, and experience in quality management systems relating to medical devices and medical device safety.

• Expert understanding and application of major medical device regulations and industry standards globally for design control, device risk management, and post-market surveillance throughout the device lifecycle •  and transfer into medical device safety processes, in particular, device vigilance, post market surveillance and design control for medical devices and drug-device combination products

• Deep understanding of product quality specifications, methods of design and quality control and their interpretation, technical aspects of production and quality assurance related to medical devices and constituent parts of a combination product

• Extensive experience interacting with, and negotiating with, Health Authorities and Notified bodies worldwide as it relates to medical devices

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• Strong leadership experience, communication skills as well as ability in networking

• Excellent and well-developed analytical thinking combined with high sense of responsibility and accountability

• Fluent in English 

The successful candidate could be based from either UK, Spain or Netherlands

Your Application:

Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.

To achieve our vision we see reward for all our employees as incredibly important and include the following list of benefits and working conditions:

• competitive salary and performance bonus
• 28 days annual leave plus bank holidays
• Private Healthcare, generous pension scheme and Life Insurance
• Employee discount scheme

• State of the art offices
• International career possibilities
• Flexible and remote working

The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.

#LI-UK

#Hybrid

Bayer welcomes applications from all individuals, regardless of age, disability, gender identity/expression, family status, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. We are committed to treating all applicants fairly and without discrimination. We continue to progressively embrace and adopt actions to advance our Diversity Equity & Inclusion (DE&I) commitments and aspirations, #ForBetter.

Bayer is committed to providing access and support for all individuals with disabilities - during the application process and beyond. Applicants with disabilities are encouraged to request any support / equipment they may need via the contact information below.

Location:

United Kingdom : Berkshire : Reading || United Kingdom : Cambridgeshire : Cambridge  

Division:

Pharmaceuticals 

Reference Code:

812879