Description

Job Responsibilities :

• Responsible for the writing of Clinical Evaluation Plans.
• Responsible for compliant writing of Clinical Evaluation Reports within this business in accordance with local procedures, client guidelines and regulatory requirements.
• Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, client guidelines and regulatory requirements
• Ensures the CER and SSR files are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed.
• S/He will develop, implement and manage an effective communication model for CERs/SSRs with cross functional business partners
• Assists in the development of schedules to ensure operating company CER/SSR timelines are met.
• Participates in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
• Supports and at times acts as an SME during audits and inspections pertaining to CER/SSR processes and reports.
• Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR process.

Requirements

Candidate Profile :

• Graduate or Post-graduate in Life-Sciences, with a minimum of 1-3 years of related job experience is required.
• Experience within the medical device industry and knowledge of clinical evaluation report, regulatory requirements, evidence generation, and CER document creation is required.
• Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common biostatistical methods is preferred.
• Regulatory/Notified Body audit experience is preferred.