Assist in securing regulatory approvals for new and existing medical devices, focusing on MDR and FDA compliance. Support the preparation, review, and submission of regulatory documents. Collaborate with cross-functional teams to address compliance challenges. Stay updated on regulatory changes and their impact on products and processes. Contribute to internal and external audits as required. Opportunities to develop technical expertise and regulatory knowledge. Key Skills and Qualifications
Background in Medical Devices. Basic understanding of MDR/FDA regulations. Knowledge of medical devices and ISO13485 compliances. Additional training or certifications in Regulatory Affairs or Medical Devices. Benefits
Competitive salary. Pension and private medical insurance. Flexible work-from-home Fridays. Clear career progression pathways. What We’re Looking For
We’re seeking an honest, intuitive, and ambitious individual who’s eager to learn and grow in the regulatory affairs field. If you’re passionate about contributing to innovative medical device projects and thrive in a collaborative environment, this role is for you!
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