Medical Devices, Regulatory Affairs Specialist

We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for novel hardware and software as a medical device (SaMD) products for distribution into worldwide markets.

Requirements

• Act as the core team member for end-to-end Regulatory Affairs input and deliverables for new product introductions and product changes across the globe
• Ensure products are brought to market on time, and sustained throughout life cycle via compliant, novel regulatory strategies
• Collaborate proactively and establish strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities and other regulatory bodies)
• Lead and enable cross-functional partnerships between Regulatory Affairs and all key stakeholders including Legal, Engineering, Product Management, Quality Compliance, Clinical Affairs and other functions at all levels within the business
• Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System
• Review and approve marketing, advertising, promotional items and labeling for regulatory compliance