In this role, you have the opportunity to
In this role, you will have the opportunity to successfully drive the Clinical Development activities for the regulatory approval and clearance of Connected Sensing Solutions. Your goal is to with the team achieve timely release of high quality solutions that have outstanding reliability to the lives they will improve.
You will report to the Head, Medical, Clinical and HEOR, Connected Care functionally and dotted line to the Business Leader for Connected Sensing.
You are responsible for:
Leads and directs clinical affairs activities to ensure completion of all deliverables for product development activities. This includes pre-clinical studies, risk management implementation, new product development processes and design history file development
Provide and drive the global clinical research strategy to bring to market medical device products and solutions
Work closely with Regulatory manager to drive these studies in accordance with appropriate quality standards including ICH/GCP, ISO and applicable FDA/global regulations along with company compliance requirements
Provide clinical research strategies, evidence development plans and study design and protocol development with cross-functional teams including Marketing, Regulatory and R&D
Accountable for team's interface and collaboration with investigators, IRB's/EC’s, FDA, Competent Authorities, external CROs/vendors, societies and associations, and company personnel
Ensure excellence in clinical trial design and project management in terms of timelines, quality/compliance and budget
Identify and assure strategies, resources and accountability are in place to achieve rapid, cost effective and well-executed clinical studies in the US and other countries
Resources allocation for statistics and data management related to the clinical studies
Act as a Subject Matter Expert in clinical trials involving complex design issues
Be the subject matter expert in pre-market safety reporting with thorough understanding of post market safety requirements
Initiate and own the Clinical evaluation report (CER) and Post Market Clinical Follow-Up Plans (PMCF) on Connected Sensing solutions
You are a part of:
As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear collaboration 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.
To succeed in this role, you should have the following skills and experience
Master’s degree, preferably in a life-scientific discipline, and a minimum of 8 years of relevant experience working in clinical, quality and/or regulatory affairs within the global medical device industry, or 10 years of relevant experience with Bachelor degree. PharmD, MD or clinically oriented PhD preferred
Experience in defining strategy for Medical Device development, preferably with adhesive sensing devices
Knowledge and experience with global medical device regulations, writing reports, medical device clinical trial practices, GCPs
Comprehensive understanding of applicable clinical research regulations in multiple regions
Familiar with medical device development regulatory requirements
Demonstrated management and cross-functional collaboration skills
Have an eye for quality and sense for detail, while keeping track of timely delivery
Can think out of the box when needed and implements effective solutions to a variety of problems; ensures solutions are consistent with organizational objectives
Practical experience with clinical research studies, in the patient monitoring or adhesive devices is a plus
Travel approximately 25%
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
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.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.