null Philips is focused on improving people’s lives through meaningful innovation. Our aim is to improve the lives of 3 billion people a year by 2030. We are undergoing an exciting transformation globally from a consumer and healthcare business into a leader in the Health & Technology space. We now have an exciting opportunity for a Regulatory Affairs Specialist. Responsible for supporting Philips UK and Ireland Sales, Solutions, and Service compliance to applicable regional regulations including general product, medical devices, IVDs, cosmetics, trade compliance, other applicable regional regulations implemented by UK and EU Competent Authorities and government agencies, in addition to device regulations from agencies such as the U.S. Food and Drug Administration. Ensuring customer requirements are met including NHS standards, private healthcare requirements and consumer needs. Responsible for local support implementation of the Quality System elements applicable to UK&I sales, solutions and service regulations. As part of the Quality and Regulatory Team working within quality system processes. As the Regulatory Affairs Specialist, you will have experience of UK and EU regulatory requirements for medical devices and IVDs. Further knowledge of other regulations such as general products, cosmetics, Radiation Protection, Trade Compliance, Export Controls, Dangerous Goods, Information Technology Service Management, Healthcare Service Standards and Regulations would be an advantage. Please note, this role will initially be based in our Guildford office . We have plans to relocate this office to create a better working space for all of our employees and as a result, from the beginning of 2021 your new work location will be Farnborough, Hampshire. Your Responsibilities Regulatory Affairs
Monitoring local regulatory landscape that impacts Philips and translate and implement these regulations into the business.
Provide continuous regional regulatory updates to applicable stakeholders and partner with Integrated Supply Chain and Cluster regulatory teams to ensure end to end compliance.
Engage in product, solutions and services development and lifecycle to ensure regulatory compliance.
Lead Regulatory registration and company self assessments where required with Government Agencies as applicable for products, solution and services in the applicable country.
Liaise with EU Authorised Representative in delivering regulatory responsibilities.
Liaise with Post Market Surveillance team to ensure awareness of communication with Regulators and if required support any escalations.
Build relations with Regulatory and Compliance SMEs with Philips and externally engaging Trade Associations.
Lead change in culture and facilitate regulatory compliance.
Local lead for transition of E2E programs related to Regulatory processes into the Markets OneQMS
Ensures traceability between Regulatory processes within Philips Excellence Process Framework and the Markets OneQMS
The RA representative in projects to drive local compliance with the applicable country regulations and global alignment with Philips standards & policies.
Provide Regulatory input and report out to the management team and management review
Support with relevant regulatory inspections and quality management system audits and follow up with formal response to any findings that impact Regulatory.
Your team Working at Philips means experience in an organisation with an incredible diversity of nationalities, skills, backgrounds, functions and challenges. We have opportunities for graduates as well as experienced professionals in everything from applied research to marketing and sales in over 100 countries. We’re a fascinating company to be part of, with a strong emphasis on cultural awareness, mutual understanding and out-of-the-box thinking. To succeed in this role, you should have the following skills and experience Education & Experience
Successfully completed Bachelor or Master’s program or equivalent
Demonstrable experience within medical device/IVD regulatory domain (other related regulated industry experience such as clinical, medicines, information technology, trade compliance would be an advantage and will be considered)
Fluent in English, verbal and written in addition to local language
Excellent verbal and written communication skills and demonstrated customer relation skills
Working knowledge of relevant UK, Ireland, EU and International Regulations (general product, medical devices, IVDs, cosmetics, and preferably other applicable Regulations in Radiation Protection, Trade Compliance, Export Controls, Dangerous Goods, Information Technology Service Management, Healthcare Standards and Regulations).
Ability to translate regulation into operational process.
Computer skills including database management, word processing and spreadsheets are also necessary.
Rigorous and precise work is compulsory.
Able to analytically assess impact to the business and the ability to quickly understand and influence
Able to proactively and independently resolve issues in a compliant way
Able to communicate across levels and cultures internally within Philips and externally representing Philips (stakeholder management)
In return, 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 competitive base salary plus a high performance related bonus.
Holiday allowance of 25 days a year from the start (plus bank holidays)
Learning and Development opportunities through our Philips University
Family friendly policies which offer enhanced maternity and paternity scheme
The Philips Employee Shop allows employees to buy Philips products at discounted prices
Subsidised Café promoting healthy eating and wellbeing at the Guildford site
Social Events - a dedicated Sports & Social committee promoting a host of social events throughout the year including the famous Family Sports Day at Surrey Sports Park.
Access to private healthcare insurance
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 . Equal opportunities 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. #LI-EU