Work Flexibility: Hybrid or Onsite
As a Senior RAQA Specialist, you will oversee Post Market Surveillance (PMS) processes across our distribution sites in Germany, Switzerland, and Austria (GSA), ensuring compliance with MDR 2017/745 and local regulatory requirements such as the Swiss MedDO. You will be responsible for managing customer complaints, field safety corrective actions, and regulatory interactions. Collaborating with global manufacturing sites and cross-functional teams, you will drive continuous improvement initiatives within a dynamic and innovative environment.
What will you do
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Ensure PMS processes comply with MDR 2017/745, ISO 13485, and local regulations, including Swiss MedDO.
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Manage customer complaints, field safety corrective actions, and regulatory reporting within the GSA region.
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Respond to requests from local competent authorities and liaise with manufacturing sites worldwide.
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Support internal and external audits related to PMS and regulatory compliance.
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Drive process enhancements to optimize PMS activities.
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Deliver impactful training and expert guidance to internal teams.
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Ensure documentation and reporting of PMS activities for continuous improvement.
What will you need
Required
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Bachelor's degree in Engineering, Science, or a related field. Master’s is a plus.
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2+ years of Regulatory Affairs & Quality Assurance (RAQA) experience, preferably specializing in Post-Market Surveillance; Complaint Handling and FSCA.
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2 years of experience in a medical device, pharmaceutical, or other highly regulated industry.
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Proficiency in English and German, with strong communication and collaboration skills.
Preferred
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Knowledge of ISO 13485, MDR, and post-market surveillance requirements.
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Hands-on experience in complaint handling,
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Experience with digital tools for complaint handling and PMS reporting.
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.
Additional information
Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of at least 1 day a week on site at our location in Duisburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
Please note that the internal job title may differ from the ad title.
Travel Percentage: 10%
Stryker Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.
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Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
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Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
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Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.
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What We Do
Stryker 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 at www.stryker.com. Together with our customers, we are driven to make healthcare better.
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