Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-teamAs a (Senior/Staff) Regulatory Affairs Specialist (m/f/d) at our Freiburg office, step into a dynamic role that not only demands excellence in regulatory affairs for our cutting-edgeCMF businessat Stryker but also offers an unparalleled learning opportunity. Harness your expertise to navigate regulatory landscapes, while immersing yourself in a culture of continuous growth and innovation, positioning you at the forefront of evolving healthcare standards and advancements.
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What will you doAs a (Senior/Staff) Regulatory Affairs Specialist (m/f/d) you will partner with cross-functional teams to prepare regulatory change assessments and technical documentation updates.You will provide input to cross-functional teams on requirements, strategies and documentation needed to maintain regulatory marketing authorizations, reviewing and approving DHF and DMR records per regulatory and quality system requirements.You will maintain accurate and up to date regulatory documentation and data in Stryker systems to ensure global market continuity of assigned products.You will participate in team meetings with colleagues based in the US, Ireland, and Freiburg teams contributing to and learning from global regulatory submission and strategy experiences.You will also support the Regulatory Affairs team with internal and external audits and ISO 13485 QMS requirements as well as other projects such as the implementation of the EU MDR 2017/745.What will you needYou have completed BS in Engineering, Science, or related degree; or MS in Regulatory Science; RAC(s) is preferred.You have gained a minimum of 1 years' experience in medical technology or another regulated sector in the area of quality, regulatory affairs or R&D.Ideally you have already acquired knowledge of the ISO 13485, EU MDR 2017/745, MDCG 2020-3, NBOG 2014-3 and / or the FDA requirements for assessing post-launch design, regulatory and production changes.You have strong time management, coordination, and communication skills, capable of executing basic regulatory tasks, supporting technical activities, and demonstrating a proactive approach to work within a dynamic regulatory environment.“Your English language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office. German is a preference.Additional informationThe position is initially limited to 18 months. Due to the large number of different positions and areas of responsibility, Stryker often offers the options of being taken on in a permanent position.Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 2-3 days per week on site at our location in Freiburg is preferred to build sustainable relationships and maintain personal contact with colleagues as well as the departments.Your applicationWe are looking forward to your online application including all relevant documents such as CV and ideally a cover letter (transcript of results, and references are welcomed). Please note to upload all attachments directly in our application procedure under the item “CV”.Please note that the internal job title may differ from the ad title.Your contact:In case you have further questions regarding the position, please feel free to directly reach out to Monika Ambroziak: monika.ambroziak@stryker.comAbout StrykerStryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available atstryker.com.
