Katalyst Healthcares & Life Sciences
Regulatory Affairs Specialist (Medical Device)
Katalyst Healthcares & Life Sciences, Boston, Massachusetts, us, 02298
Regulatory Affairs Specialist (Medical Device)
ContractKatalyst 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:Utilizing gathered legacy medical device technical files, construct a draft STED file based on standard client format.In assembling the draft STED file, review current state of legacy medical device technical files to identify any gaps in compliance with 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, Essential Requirements Checklist.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.Requirements:Requires BA degree in a science or related field.At least 5 years relevant experience within the regulatory affairs discipline.Knowledge of EU medical device regulatory requirements.Experience with Class IIb/IIa devices is mandatory.Ability to work independently with minimal supervision.All your information will be kept confidential according to EEO guidelines.
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ContractKatalyst 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:Utilizing gathered legacy medical device technical files, construct a draft STED file based on standard client format.In assembling the draft STED file, review current state of legacy medical device technical files to identify any gaps in compliance with 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, Essential Requirements Checklist.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.Requirements:Requires BA degree in a science or related field.At least 5 years relevant experience within the regulatory affairs discipline.Knowledge of EU medical device regulatory requirements.Experience with Class IIb/IIa devices is mandatory.Ability to work independently with minimal supervision.All your information will be kept confidential according to EEO guidelines.
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