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Over de functie
Philips Medical Devices is one of the global leaders in the field of medical device production. We are looking for regulatory affairs specialist who are ready to embrace a challenge in an innovative environment!
The Regulatory Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
- Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
- Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
- Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
• Communicate application progress to internal stakeholders
• Maintain regulatory files and tracking databases as required
• Provide audit support
Are you the right candidate?
- Bachelor’s degree (Master’s preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
- RAPs RAC strongly preferred. ASQ certifications also desirable.
- Minimum of 5 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II and class III, etc.).
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards, including ISO14971, IEC 60601 and related particular standards.
- Preferably personal experience with successful preparation and submission of 510(k) and/or PMA submissions.
- Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 highly desirable.
- Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
- Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
- Proficient knowledge of domestic and international standards.
- Strong background in Design Controls.
- Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
- Understand LEAN concepts, methodologies and deployment.
Philips is internationally known for its attractive employment conditions. This role offers the opportunity to gain international experience since the candidate will travel to the U.S. regularly.
Make an impact on the world as well as your team.
You've already achieved a lot but now you're at a point in your career when you expect more and want to make a change for the best. Working at Philips will give you an opportunity to do just that, because we're a company with a big ambition.
It's our mission to improve people's lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.
To fulfill your potential, we'll give you the flexibility, stimulation and opportunities to keep you inspired and engaged. After all, working at Philips is more than just a job. It's an experience filled with surprising moments that will transform you in lasting and positive ways, as together we improve the world for the better.
Voor meer informatie neem je contact op met Rajeev Girjasing via telefoonnummer 06-22276866
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.