You can't change the direction of the wind, but you can adjust your sails to always reach your destination
Over de functie
In this role, you have the opportunity to contribute with your regulatory skills to the innovation of products and services focusing on improving people’s health. You and your team heave strong interaction with development teams on RA matters. You are part of the site MT and Business Unit MT and will be reporting to the Safety, Compliance & Regulatory Affairs Senior Director.
You will be located in Eindhoven.
You are responsible for
- Developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
- Product registrations/approvals
- Leading regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
- Providing the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE Marking, product registrations, and clinical evaluations.
- Acting as a partner of the business and helping to develop business plan from a regulatory perspective. In the product scope are new consumer regulated products and services
To succeed in this role, you should have the following skills and experience
- Master degree
- A minimum of 10 to 12 years working experience of which at least 5 years in Regulatory Affairs
- Preferably also experience in R&D
- Working experience in Medical Device (class 1 and 2) is required, Cosmetic experience is nice to have
- Experience in Project management within RA
- FDA and MDD experience is required
- Influencing and consulting skills
- Strong communicative and stakeholder management skills
- To be able to work in a constant changing environment
- Prepared to travel up to 10% globally
Philips is driven by their mission to improve the lives of 3 billion people per year by 2025, and every day they move closer to achieving their goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to their employees who share their passion for improving lives, they are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. They enable their employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.
At YACHT we will offer you a competitive benefits package in line with the seniority of the position.
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Sciences industry.
You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals.
Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer 06-13888330
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.