Quality and Regulatory Affairs Specialist (6 Month Contract)

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We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

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.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.