Quality and Regulatory Affairs Specialist (6 Month Contract)

Work Flexibility: Hybrid

Job Description

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.

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