Philips Q&R Manager in Guildford, United Kingdom
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 2025. 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 Q & R Manager for a 9 month fixed term contract.
As the Q & R Manager you will be responsible for ensuring Philips Healthcare Sales and Service compliance to applicable regional medical device regulations from agencies such as the U.S. Food and Drug Administration, EU Competent Authorities, Japan MLHW, China SFDA and other regional regulations for processing or administration of Customer Feedback & Complaints, Medical Vigilance Reporting and Product Approval applications.
You will be responsible for local support in maintaining the Quality System elements applicable to UK&I sales and service including doc control, CAPA, audit, monitoring, training and support of other functions in purchasing controls, calibration and risk assessments.
Post-Market Surveillance Management
Regional Management, monitoring & stimulation of the Philips customer feedback & complaint process including the receipt and subsequent closure of field related issue (per regulatory agency requirements when required)
Drive mandatory Field Change Order (FCO) regulatory communication timely execution
Approve measures to prevent unintended use
Ensure escalations to Business Unit (BU) / Business Line (BL) and European Representative
Monitor above mentioned processes effectiveness and takes the necessary corrective actions
Deploy & adapt when necessary training for use in the region
Review the BU / BL Quality & Regulatory (Q&R) communication when necessary
Identify trended issues, which might have an impact on regulatory exposure
Regulatory Affairs Management
Drive compliance with the applicable country regulations and Philips Healthcare (PH) standards & policies
Drive regional medical product approvals process and submissions when relevant (excluding 510K and CE Medical marking under BU / BL responsibility)
Obtain approvals within the marketing identified timeframes and provides information to sales organizations in each region regarding the status of agency product approvals
Support with the relevant regional organization and the assigned Quality Manager, the regulatory inspections conducted by safety agency investigators and directs the formal response to any negative findings
Provide overview, analysis and interpretation of regulatory issues and requirements as well as consequences on quality management system, business and budget
Organize & monitor with regions the government liaison structure with officers of country regulatory agencies to include medical device, environmental, nuclear, and other regulatory bodies
Support the Q&R market lead in the development of detailed written responses to competent authority inquiries and warning letters to assure Philips continued ability to ship products in the region / country /district
Assist public relations efforts on regulatory issues, i.e. governmental efforts, regulatory Warning letters and product recalls
Organize & monitor Philips regulatory representation at regional / county trade or industry associations
Supervise post-market surveillance officer and / or Quality & Regulatory Affairs officer on the quality and handling of customer feedback and post market surveillance.
Provide quality leadership locally to drive a culture across the organization to support align of PQMS and compliance to regulation and standards.
Provide data and analysis for quality management review
Maintains, enforces, and manages a compliant and effective Markets OneQMS
Supports transition of E2E programs into the Markets OneQMS
Ensures traceability between Philips OneQMS and the Markets OneQMS
Ensures that controlled Quality documents are maintained to the latest issue
Supports a proper audit schedule, planning and execution in the Market meets the requirements of internal policies and external regulations
Supports the PQMS Managers with regards to local issues
Check quality documents localization to market need and regulation.
Working at Philips means driving your career 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.
This role is based in our Guildford office where we operate an agile working environment.
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.
Access to private healthcare insurance
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 schemes
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 with members in Guildford and Cambridge, promoting a host of social events throughout the year including the famous Family Sports Day at Surrey Sports Park.
We are looking for
Education & Experience
Successfully completed Bachelor or Master’s program or equivalent
Demonstrable experience within quality domain (preferable in medical devices or any other strong regulated industry)
Certification as internal auditor highly desired
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 international/local ISO/device Regulations (ISO 14971-Risk Analysis, ISO 13485, relevant product approval regulation).
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 Markets OneQMS and the local organization of E2E programs, including the ability to understand and develop processes
Able to proactively and independently resolve issues in creative ways
Able to communicate across levels and cultures of the organization (stakeholder management)
Please apply on-line – Good Luck!
Recruitment agencies : we are fortunate enough to receive lots of fantastic applications for our brand, however when we use agencies we have a PSL in place so please do not contact hiring managers or the recruitment team directly. Unfortunately we are not able to respond to you and cannot accept speculative CV’s as way of introduction.