About the job
The Senior Manager Regulatory Affairs at ONWARD Medical holds a pivotal role in leading the Regulatory Team. You are responsible for defining the regulatory pathway, providing expert regulatory guidance and support to technical teams throughout the product lifecycle, from design and development to evaluation, labelling, and marketing. Your primary focus is ensuring regulatory compliance with applicable standards.
Responsibilities
Act as PRRC (Person Responsible for Regulatory Compliance) per MDR Article 15
Provide crucial regulatory support to the development team for the creation of a comprehensive Design History File and Technical Documentation.
Collaborate closely with cross-functional teams, offering regulatory guidance in all aspects of product design, development, evaluation, labelling, and marketing.
Oversee packaging and labelling requirements.
Create Submission Files in accordance with 21 CFR 820 and with the General Safety and Performance Requirements (GSPR) checklist.
Drive and coordinate FDA submissions, working closely with both internal teams and external consultants.
Continuously assess the current regulatory activities against newly published guidance related to the Medical Device Regulation (MDR) and standards.
Conduct traceability and compliance assessments to demonstrate adherence to applicable standards (e.g., 14708-1, 14708-3, IEC 60601-1), and collaborate with test houses as needed.
Collaborate with the engineering team to execute Failure Modes and Effects Analysis (FMEA) in alignment with ISO 14971 requirements as part of technical file updates.
Actively participate in ISO audits and provide valuable support to the Quality department in preparing for these assessments.
Lead, mentor, and manage a team of Regulatory Specialists.
