Medical Writer

July 24

Apply Now

Receive Emails with Similar Jobs

Exactech

WebsiteLinkedInAll Job Openings

Exactech is a global medical technology company that empowers orthopaedic surgeons with innovative implants, surgical instruments and the Active Intelligence® (AI) ecosystem of smart technologies to give patients EXACTLY what they need to regain mobility$1. .$1

Orthopaedic • Medical Device • Orthopedic • Implant • Surgical Instrumentation

501 - 1000

Description

• Provide medical writing and research services in support of Regulatory activities • Clinical Research activities • Product risk/benefit assessments • Innovation

Requirements

• Prepare clinical evaluation reports for submission to regulatory bodies to support new product registrations or continuing registrations. • Perform data analysis of clinical outcomes data from internal and external sources. • Perform literature reviews according to recognized scientific methodologies. • Work with other functional areas to feed back the analysis of post-market information into Risk Management and the Design and Development process. • Develop and support risk/benefit analyses. • Independently manage multiple medium to large scale writing/research projects. • Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification, including the application of Design Control and Risk Management processes. • Participate as needed in the complaint handling, corrective and preventive action and internal quality audit processes.

Benefits

• Providing knowledge and support to the company’s different business units to enable operation within company and regulatory guidelines. • Assisting and supporting other employees, teams, and sales personnel as necessary. • Practice Exactech’s Values. • Know and apply the Quality System and any appropriate Federal and International standards