The MDD/MDR Specialist is responsible for ensuring that the company’s software which is used as a medical device complies with the Medical Device Regulation (MDR), and ISO 13485 and 14971 standards. This role involves augmenting and maintaining the quality management system, managing regulatory submissions, and ensuring compliance with all relevant regulations.
Key Responsibilities:
Lead the preparation and submission of regulatory documentation for new and existing medical devices in compliance with MDD, MDR, and ISO 13485.
Maintain and update the quality management system (QMS) to ensure ongoing compliance with MDR, ISO 13485 and ISO 14971 standards.
Conduct gap analyses and implement necessary changes to meet regulatory requirements.
Collaborate with cross-functional teams, including the quality auditor, marketing, and quality leads, to ensure regulatory compliance throughout the product lifecycle.
Monitor and track regulatory changes and provide guidance to the organization on the impact of these changes.
Support the Preparation of and advise on the submission of post-market surveillance reports, adverse event reports, and other regulatory submissions as required.
Support internal and external audits by clients and regulatory bodies.
Provide training and support to staff on regulatory requirements and quality management systems.
Support and review and updated DTAC submissions in the UK and similar standards in other EU countries as applicable.
Qualifications:
Bachelor’s degree in a scientific, engineering, or related discipline
experience in regulatory affairs and quality management systems in the medical device industry Preferred
Strong knowledge of MDD, MDR, and ISO 13485 standards and requirements.
Experience with regulatory submissions to the FDA, EU, and other global regulatory bodies preferred.
Excellent project management, analytical, and organizational skills.
Strong communication and interpersonal skills.
Preferred Qualifications:
Experience with CE marking and FDA submissions. Knowledge of ISO 14971 and FDA QSR Part 820.
Prior experience in a manufacturing or device design authority environment.
Apply via :
jobs.iqvia.com