We are seeking a Quality & Regulatory Affairs (QRA) Specialist on a six-month contract to provide immediate support in post-market surveillance and regulatory reporting activities.
This role focusses on delivering quick impact by supporting core complaint handling and vigilance processes.
Key Areas of Responsibility:
- Assures post-market regulatory requirements are met (e.g. required reports, supplemental submissions and other post-marketing commitments).
- Reviews complaints and assesses them for regulatory reporting, within defined timelines.
- Reviews and approves complaint investigations.
- Handle all necessary complaint handling process activities.
- Submit initial and follow-up reports to device related Agencies as needed, within defined timelines.
- Works with quality investigators, local teams and customers on gathering information for reportability decisions.
- Supports service review and complaint intake activities, if needed.
Education / Work Experience:
- BS in Engineering, Science, or related degree; or MS in Regulatory Science.
- Some relevant experience preferred.
Knowledge / Competencies:
- Under supervision, performs work that is varied and involves limited responsibility.
- Clearly conveys information to peers, supervisors, and other stakeholders.
- Holds a general awareness of the business, products, and customers.
- Knowledge of defibrillator products preferred.
- Knowledge of applicable and international regulations and standards preferred, specifically:
- Knowledge of 21 CFR Part 820, Quality System Regulations.
- Knowledge of 21 CFR Part 803, Medical Device Reporting.
- Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA Statute.
- Knowledge of the European Medical Device Regulation (EU MDR) 2017/745.
- Knowledge of General Data Protection Regulation 2016/679.
- Knowledge of ISO 13485:2016 Medical Devices.