MDR, and ISO 13485 Specialist
MDR, and ISO 13485 Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
The MDD/MDR Specialist is responsible for ensuring that the companys 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 crossfunctional 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 postmarket 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:
Bachelors 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.
Key Competencies:
Attention to detail and strong problemsolving skills.
Ability to work independently and as part of a team.
Proactive and able to manage multiple projects simultaneously.
Strong sense of ownership and accountability.
Working Conditions:
Hybrid role with a requirement to be at the office 2/3 times/week for the first 6 months and then more flexibility will be available.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Unclear Seniority
Employment Type
Full-Time
