As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
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· Advise business Regulatory Affairs and Clinical Affairs (RACA) teams on regulatory and clinical strategy and requirements for specific new products/solutions in the markets.
· Plan and facilitate all regulatory submissions and product registration certificate renewals, including for new products/solutions, existing products/solutions, local permits, and site registrations.
· Support clinical investigation notifications / approval requests to applicable authorities in the markets.
· Review and validate local marketing and labeling materials in the markets.
· Ensuring compliant, effective and efficient Regulatory and Clinical Affairs processes in the markets.
· Ensuring necessary relations with respective regulators in the applicable markets are built and maintained such that the market RACA team knows and understands the market and business consequences of changing and new regulations and pro-actively work with our business partners in the markets and the business to transfer this knowledge and understanding such that Philips will be timely prepared
· Partners with the Governmental Affairs, Global Regulations & Standards team to align RACA activities and representation of Philips in the necessary industry associations like COCIR and / or EUCOMED or local associations.
· Might act as the EU authorized representative for various Philips Healthcare products in the markets or ensure that this task is delegated.
Responsibilities
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
Key areas of responsibilities (KARS) for this role include:
• Advise business RACA teams on applicable regulations, requirements, and standards through the development of regulatory plans.
• Lead RACA programs to ensure the highest level of compliance.
• Develop market submission strategy for new products/solutions (to include definition of all deliverables and/or localization required).
• Direct markets medical product approvals process and submissions when relevant. (Note: supports CE Medical marking which is under Business Group responsibility. The 510K process is completely excluded).
• Plan, generate, manage and coordinate regulatory submissions for product/solution licensing.
• Coordinate testing required to support regulatory submissions in specific markets.
• Maintain existing regulatory filings/ licenses, managing updates and related change control processes
• Establish and deploy systems to ensure that the information required for all required reports, product registration certificate renewals and submissions are clearly identified can be easy retrieved. This includes the creation of a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals
• Review and approve localized product/solution labeling and product/solution-related marketing communications and ensure that all medical and technical claims are underpinned with evidence obtained by business Q&R.
· Ensure completion and receipt or submission of regulatory and compliance documents (e.g., Declaration of Conformity, Product Registration Notification, Export License, Safety Agency Approval, etc.)
• Manage export documents required to support global registration.
• Support global registration by ensuring Free Sales Certificates are timely available from the EU representatives, for product with legal manufacturer in EU that need to be exported from the EU
• Manage the medical device manufacturer/distributor state licensing process for Philips facilities.
• Direct an effective, compliant and efficient RACA approval process for necessary local 3rd party medical devices and related products.
• Own and maintain the applicable regulatory deliverables database(s) across all Philips businesses, creating a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals
• Support the business with Clinical Study execution in the markets, in particular submitting the clinical study notifications or approval request to the applicable authorities and act as a liaison between Business RACA and authorities.
• Directs the “virtual” market RACA team to ensure most effective, compliant and efficient (with shortest lead time to market) product approval processes. This team also liaisons with our distributors in the indirect markets to ensure that these distributors can bring our products to the market in an effective and efficient way from a regulatory perspective.
• Organize with markets the government liaison structure with officers of country regulatory agencies to include medical device, environmental, nuclear, and other regulatory bodies.
• Directs necessary supportive localization efforts in the markets, in addition to the localization efforts executed by the business groups who are primary responsible for localization, to ensure effective and efficient market access for our products.
• Directs the market RACA team to build and maintain the necessary relations with respective regulators in the applicable markets in order to know and understand the market and business consequences of changing and new regulations and pro-actively work with our business partners in the markets and the businesses to transfer this knowledge and understanding so that Philips will be timely prepared for continuously having maximum product market access and shortest market approval processes.
· Direct local Philips representation in local industry associations to not only collect information on new and changing regulations, but also pro-actively influence development of new or changing regulations in the benefit of our customers, our business and our other stakeholders. Also partners with the Philips Government Affairs and the Global Regulations & Standards team to align RACA activities and representation of Philips in the necessary global / European industry associations like COCIR and EUCOMED.
· Pro-actively advises and counsels the Head of RACA, Q&R Group and the Head of Q&R Markets by providing analysis and interpretation of Market RACA Regulatory issues, KPI’s and requirements as well as consequences of these on the effectiveness of the Quality Management System, business and budget. This includes the necessary RACA input to the management review process.
· Support the relevant organizations with regulatory inspections conducted by agency investigators and directs the formal response to any negative findings. Immediately inform the Head of RACA, Q&R Group and the Head of Q&R Markets after becoming aware of any (intention of) such inspection and continuously keep the Quality Leadership Team informed about the results of such inspection.
· Represents the Market RACA in applicable Philips, PQMS and other relevant improvement Projects.
Your team
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
The role reports solid line to the Head of Regulatory & Clinical Affairs, Group Q&R and dotted line to the Head of Q&R markets.
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