Lead the preparation and maintenance of technical documentation, including the Technical File and Design Dossier, according to EU-MDR 2017 requirements.
Collaborate with teams to ensure completeness and accuracy of technical documentation for product registrations and conformity assessments.
Faced the audit of the notified body
USFDA Registration:
Manage the preparation and submission of 510(k) applications, IDEs (Investigational Device Exemptions), and premarket approval (PMA) submissions to the USFDA.
Provide strategic guidance on regulatory pathways for product clearance and market authorization in the United States.
Liaise with USFDA officials during inspections, audits, and communications.
ISO 13485 Quality Management:
Develop and maintain the Quality Management System (QMS), including the preparation of the Quality Manual and Standard Operating Procedures (SOPs) in compliance with ISO 13485 requirements.
Oversee internal audits, CAPA processes, and training programs to ensure adherence to quality standards and regulatory requirements.
Implement ISO 14971-compliant risk management processes across the organization.
Regulatory Strategy Development:
Formulate global regulatory strategies for product registrations and approvals in key markets, considering EUMDR, USFDA, and other applicable regulations.
Stay abreast of the evolving regulatory landscape and advise on regulatory implications for new product development projects and lifecycle management.
Technical Documentation and Submissions:
Lead the preparation and maintenance of regulatory submissions, technical files, design dossiers, and other documentation required for product approvals.
Ensure timely and accurate submission of regulatory documents to authorities and notified bodies.
Cross-functional Collaboration:
Collaborate closely with RD, Quality Assurance, Manufacturing, and Marketing teams to integrate regulatory requirements into product design, development, and commercialization processes.
Provide regulatory guidance and support throughout the product lifecycle, from concept to post-market surveillance.
Regulatory Intelligence and Compliance Monitoring:
Monitor changes in regulations, guidelines, and standards affecting medical devices and IVDs.
Assess the impact of regulatory changes on existing products and ongoing projects, and implement compliance initiatives as necessary.
Notified Body and Regulatory Agency Relations:
Build and maintain relationships with notified bodies, regulatory agencies, and industry associations.
Represent the company in regulatory interactions, meetings, and audits to facilitate product approvals and regulatory compliance.
Requirements:
Bachelors degree in a scientific or engineering discipline; advanced degree preferred.
Minimum 7 years of progressive experience in regulatory affairs within the medical device industry.
In-depth knowledge and experience with EUMDR 2017, USFDA regulations (including 21 CFR Part 820), and ISO 13485 standards.
Proven track record of successful regulatory submissions and approvals.
Strong project management skills with the ability to prioritize tasks and meet deadlines.
Excellent communication and interpersonal skills for effective collaboration.
Detail-oriented mindset with analytical problem-solving abilities.
Experience in developing quality manuals, SOPs, and technical documentation.
