Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
\rWe are proud to be named the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
\rAre 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 Regulatory Affairs 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!
\rNeed another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
Your key responsibilities
For the first 2 years you will work in a dedicated, cross functional and energetic project team implementing the EU MDR (Medical Device Regulation) requirements within the Trauma & Extremities Division.
In your new role as (Senior) RA Specialist you organize and implement strategies and activities required to procure regulatory approval for new and revised product lines.
You ensure compliance to all US, EU and international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products.
You apply scientific principles to understanding safety and efficiency on a wide range of products.
You interface and coordinate with the FDA, Notified Bodies and other regulatory agencies on submissions, approvals or other issues.
You support R&D, marketing and manufacturing teams in regulatory assessment of proposed changes or product transfers.
Moreover, you participate in cross functional team activities from initial stages through securing government approvals for any initiative and project requiring Regulatory Affairs support.
What are we looking for?
You have a Bachelor’s Degree in a scientific discipline. Ideally, you hold a RAC certification.
You hold several years of experience in a highly regulated industry and you have working knowledge of Medical Device Regulations (FDA/MDD required, additional international a plus).
You have gained experience with 510(k), EU MDD 93/42/EEC Technical File/Design Dossier preparation and/or EU MDR 2017/745 Technical Documentation preparation.
You have successfully interacted with the FDA and notified body reviewers/inspectors and you have a sound understanding of scientific principles.
You are fluent in English and have ideally a good knowledge of German.
Contact: For further questions, please feel free to reach out to Lisa Buch via +49 175 8061763.
Our total rewards offering varies by country but often includes bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.
\rBe sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at careers.stryker.com/referrals/