What are the responsibilities and job description for the RA(Regulatory Affairs) Specialist position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Job Description:
- Responsible for the development of Summary Technical Documentation (STED) for CE marking to integrate varied technical files for Class IIb/IIa/I sterile/I renal replacement therapy medical devices under a standardized format.
Rsponsibilities:
- Utilizing gathered legacy medical device technical files, construct a draft STED file based on standard Baxter format
- In assembling the draft STED file, review current state of legacy medical device technical files to identify any gaps in compliance with Baxter procedures and requirements of Medical Device Directive MDD 93/42/EEC (amended by 2007/47/EC). Areas of focus include, but are not limited to:
- Product Labeling
- Clinical Evaluation Reports
- Testing Summaries
Requirements :
- Review design changes made to ensure the legacy medical device technical files are accurate to the current design of the device; identify gaps.
- Summarize gaps and recommend corrective actions
- Work with cross-functional teams consisting of R&D, Quality and Regulatory to gain concurrence on gaps and needed actions to address
- Develop plan and track progress for actions that address gaps
- Review outcomes of actions that address gaps to ensure they are complete and accurate in their deliverables
- Maintain vigilance in continued changes to medical devices over the course of developing the STED.
- Finalize the STED and present to cross-functional team for their review and approval
- Update the completed STED based on changes made during the course of the project, as required
- Determine and present the impact of updated STED content on global registrations
- Maintain and communicate progress at weekly team meetings
Additional Information
All your information will be kept confidential according to EEO guidelines.
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