Company:
Katalyst Healthcares & Life Sciences
Location: Boston
Closing Date: 22/10/2024
Salary: £125 - £150 Per Annum
Hours: Full Time
Type: Permanent
Job Requirements / Description
Regulatory Affairs Specialist (Medical Device)
Contract
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:
- 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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Katalyst Healthcares & Life Sciences