In this role, you have the opportunity to
Provide Regulatory support for New Product Development and Sustaining efforts in both the domestic and international markets for assigned medical devices. You will directly support registration and licensing in the US, Canada and EU and indirectly support the International Market groups for all other licensing. You will work as a Regulatory Operations Specialist on problems of diverse scope where analysis of regulatory data requires evaluation of identifiable factors. The development of the solution requires a multi-disciplinary approach and knowledge of regulatory principles, theories and concepts.
Please note, this role will initially be based in our Basingstoke office. We have plans to relocate this office to create a better working space for all of our employees and there is a strong possibility that by the end of 2020, your new work location will be Farnborough, Hampshire
You are responsible for:
Plan, generate, and coordinate worldwide regulatory submissions for product/solution licensing, and maintenance of existing regulatory licenses, including change submissions and associated submission testing activities.
Develop and maintain Technical Documentation Files in accordance with EU regulation. Prepare regulatory documentation such as biological evaluation files, clinical evaluation reports, and essential requirements / GSPR checklists.
Develop regulatory plans and provide regulatory input which ensures regulatory requirements are met and maintained throughout the product marketing lifecycle, including new product introductions and product changes.
Provide senior regulatory support to product development teams throughout the design control process, including the analysis of applicable standards, guidance on risk assessment and effective implementation of the regulatory plans.
Responsible for implementing global regulatory strategy and roadmaps through understanding the competitive market landscape and product marketing strategy.
Review the impact of changes to standards and regulations, assisting with any required conformance and engineering change activities.
Support the Regulatory team with other regulatory-focused activities as required.
Independently manage multiple projects, department initiatives, and day-to-day tasks.
You are a part of:
A global company within a business providing remote monitoring and resuscitation solutions for pre-hospital and critical care services that are truly lifesaving . A fast growing and innovative Quality & Regulatory team, within an ever-changing environment, located in Basingstoke, UK. The Quality & Regulatory team enables meaningful innovation for our customers by collaborating with and guiding the business to achieve quality and regulatory compliance in a rapidly changing environment.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree with demonstrable related experience in regulatory affairs . Unique combinations of education and experience may be substituted if they provide the essential skill sets for the position
Ideally experiencewithsuccessfulpreparation and submissionof US Class II510(k) and US Class IIIPMA.
A broad depth of worldwide medicaldeviceregistrations
Experience gained in a medical device company with higher risk devices in EU Class IIb and EU Class III and their equivalent classifications in other regulatory systems
Strong background in Design Controls
Excellentworkingknowledgeofmedicaldevice regulations (21CFR), FDA law, MDD/MDR , other globallaws and regulations
Experience in electro-medical devices (IEC 60601 series) and medical device software (IEC 62304, IEC 82304) is highly desirable
Experience of radio equipment regulations (e.g. RED, FCC) is desirable
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
A market conform salary
25 Days of leave and the possibility to purchase up to 5 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there,you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
Philips are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.
Should you require any reasonable adjustments to enable your participation in the interview process, please advise us of this in your application.