Our client is the global number one manufacturer of choice for our partners who are looking for the highest quality and best service in the field of Orthobiologic Ceramics. We are working with the leading companies in the medical & dental (device) industries, start-ups with compelling business ideas and engaged universities. We co-op with our customers in the United States, Europe, Asia and in Emerging Markets. We will continue to seek and deploy technological and engineering advancements. If you’re passionate about your field, we have a wide array of positions available at our HQ in Leiden. The environment is innovative, energetic and full of opportunity. Our company thrives on a diverse workforce. Due to growth in our company, we are looking for an experienced RA officer/ Manager to lead, guide our Regulatory Affairs department. As a (Sr.) Officer/Manager within a fast-growing contract development and manufacturing organization you will be reporting into the QA/RA/QC Senior manager
What we are looking for
To ensure the consistency of our trustworthy services and the production of our Medical Devices, we follow our processes strictly under ISO13485 Quality management system standard. We are looking for an (Sr.) RA Officer/Manager who can manage and help to roll out our Regulatory Affairs strategy under the new EUR MDR 2017/745 standard.
What are your responsibilities?
- As part of the QA/RA/QC team in Leiden you will lead our Regulatory strategy development for the related markets in coordination with related stakeholders within our client
- Lead and coordinate all relevant regulatory topics for our client to ensure a smooth process end to end is in place
- Staying on top of all relevant policy topics, connecting stakeholders, gathering policy intelligence and execute the regulatory strategic direction for our client to achieve commercial objectives
- Helping to drive a regulatory strategy for the company for the local trade associations and influencing the regulatory environment via interactions with Authorities and Trade Associations
- Contribute to internal knowledge management and intelligence as needed
- being key regulatory subject matter experts for CAM Bioceramics BV
- Support EU MDR deployment in markets as needed.
- Create the center of excellence Regulatory within our client to ensure better efficiency.
Who Are you?
- Bachelor or master’s level of education in Health Sciences or engineering
- At least 5-7 years’ experience in regulatory activities in the medical devices industry including involvement in the preparation and submission to local authorities is ideal.
- Knowledge and experience of EU MDD, EUMDR and MEDDEV
- Experience in leading and driving Regulatory strategy and Regulatory project (s) with an effective action plan and deployment.
- Experience in building contacts with local authorities in Europe with tangible actions and outcome.
- You have strong influencing and communication skills and the ability to take complex regulatory topics and communicate them to a varied audience.
Maybe this is the great next step in your career, or if you have questions regarding this oppertunity we will kindly ask you to contact ROBERT WHITE Staffing Solutions B.V. and ask for Robert de Wit via: firstname.lastname@example.org or call +31(6) 46 70 92 18