Medical Device jobs in United Kingdom

Senior Medical Device Safety Lead

Major Tasks:

1. Generate concepts, define strategies and actively implement medical device PMS and Vigilance standards within the function Pharmacovigilance (PV), Medical Device Safety (PVMDS) and beyond, as a medical device expert serving Bayer Pharmaceuticals and Bayer Consumer Health globally.
2. Manage and provide content contributions to the medical device vigilance system including reporting to health authorities worldwide, system processing, documentation and training, serious incident electronic reporting, vigilance compliance monitoring for serious incidents and serious public health threats, trending and reporting for non-serious incidents and periodic summary reports.
3. Manage and contribute to the post-marketing surveillance (PMS) program activities including PMS system documentation, PMS planning and report management, PMS trending methodologies, analysis and written contributions, management of PMS Trending and Review Board for performance and safety, and device PSUR & Annual Review Board.
4. Provide NPD contributions to design control for medical devices throughout the AS process.
5. Interpret global regulations for execution and recommend modifications to operational procedures to ensure continued compliance and state of the art industry conformity.
6. Represent PVMDS during Health Authority inspections and both announced and unannounced Notified Body audits; review, respond and implement corrective and preventative actions with respect to medical device vigilance and PMS from audit and inspection findings.
7. Represent PVMDS organizationally and during governance activities required for successful operation of processes across multiple divisions, functions, sites and diverse cultures globally.

Who you are:

1. Degree in Engineering or Life-science Discipline with significant medical device industry experience and professional industry experience in quality management systems relating to medical devices and pharmacovigilance.
2. 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 life-cycle (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).
3. Expert knowledge of worldwide medical device legislation and regulations and how to translate this into medical device safety processes.

What we offer:

• Competitive compensation package consisting of an attractive base salary and annual bonus. Individual bonus can also be granted for top performance awards.
• Mobility Benefit
• 28 days annual leave plus bank holidays
• Private Healthcare, generous pension scheme and Life Insurance
• Wellness programs and support
• State of the art offices
• International career possibilities
• Flexible and Hybrid working
• Help with home office equipment
• Support for professional growth in a wide range of learning and development opportunities
• We welcome and embrace diversity providing an inclusive working environment

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.

Bayer is committed to providing access and support for all individuals with disabilities and/or long-term conditions - during the application process and beyond. Let us know if there is anything about the recruitment process that you would like to discuss, in particular if there are any changes or adjustments that would make it easier for you to apply.

Location:

Division: Pharmaceuticals

Reference Code: 833455