eojilo.blogg.se - Regulatory medical writing

Regulatory medical writing registration#

Evaluate the risk of proposed regulatory strategies in the context of sufficient clinical data and offer solutions as applicable.Work cross-functionally to ensure successful preparation of high-quality submission-ready clinical documentation.Maintain periodic updates, perform gap analysis, and revise existing documents as necessary.Review/edit clinical regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures to ensure all data and information is truthful, accurate, and verifiable against source documentation to confirm compliance and traceability.Write, edit, and proofread Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, and Summary of Safety and Clinical Performance (SSCP) in accordance with regulatory requirements.

Conduct technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.

IIS clinical data, as available) and synthesize the information to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling change.

Research and compile clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g.

Regulatory medical writing registration#

The Regulatory Affairs Senior Medical Writer will support MDR device registration efforts in the European Union (EU) by writing Clinical Evaluation Plans, Clinical Evaluation Reports, Post-market Clinical Follow-up Plans, Post-market Clinical Follow-up Reports, and Summary of Safety and Clinical Performance documents and collaborating on a number of other clinical and regulatory documents. Competitive compensation and a generous relocation package offered! Join our talented Regulatory Affairs team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™. This position is on-site and based out of the Arthrex Corporate Headquarters in Naples, Florida. The successful candidate will work alongside a department of expert regulatory and orthopedic healthcare professionals, world class medical education, and product development. The Regulatory Affairs department is actively searching for a Senior Writer for our Medical Writing function. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. is a global medical device company and a leader in orthopedic new product development and medical education in orthopedics. Senior Medical Writer, Regulatory Affairs - CER Medical WritingĪrthrex, Inc.