€ 35,000 - € 50,000
Detachering via YER
Manufacturing, Medical & Health
Over deze vacature
Your challenge is to develop and execute product approval regulatory strategies for product development teams; ensure compliance with all applicable domestic and international standards and regulations that pertain to regulatory approval and maintenance on the market; interpreting regulations and guidelines; prepare and execute regulatory plans; provide guidance while participating on cross functional medical device development teams.
Develop, review and approve product labelling and literature, advertising and promotional materials as required. Ensure that overall regulatory activities are conducted and documented in accordance with US FDA requirements and guidelines, applicable international requirements and guidelines, and company procedures.
Working in the medical device industry brings much fulfilment, 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 Food and Drug Administration (FDA).
- Develop strategies for product submissions/registrations in accordance with current worldwide regulations and guidelines in support of the IGT Systems Business Unit
- Reviews and approves product release status for new products, marketing materials, product development documentation including but not limited to risk management documentation, test plans and reports, product specifications, product labelling
- Prepare and oversee as necessary the preparation of FDA submissions; 510K's, IDE's, PMA's, etc.
- Prepare and oversee as necessary the preparation of European registrations for new or modified products; CE marking, design/technical dossiers, etc.
- Prepare and oversee as necessary the preparation of international product submissions
- Maintains technical reports & certifications from regulatory agencies
- Oversee various compliance activities/processes as needed including employee training on regulatory topics
- Assist and lead other projects as required
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
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 Centres 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.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to Philips.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist, a fixer who continuously strives for excellence as a way of life; not just as in the job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
- Bachelor's degree in Health Sciences, Biomedical engineering or related field required. Master's degree desirable
- A minimum of 3 to 5 years in the regulatory affairs field
- Good to have: Demonstrated medical device experience; US 510K, IDE, and PMA submissions; European CE marking experience with Class III Design Dossier and Class IIa/IIb Technical File
- International regulatory submission experience
- Previous practical experience in regulatory activities in cardiovascular medical device applications highly desirable
- Ability to work well in a matrix organization