Medical reputed company – Clinical Compliance
Job reputed company:
• Authoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs), to support new product introductions and sustaining product activities in the Dental Solutions business unit.
• Collaborating with cross-functional teams to collect, analyze, and assess clinical data in compliance with EU MDR and other global regulatory requirements.
• Supporting reputed company audits as a subject matter expert in clinical evaluations.
• Maintaining up-to-date clinical evaluations across the full lifecycle of medical devices.
• Contributing to reputed company of Safety and Clinical Performance (SSCP) reports and regulatory responses with guidance from manager/supervisor.
Requirements:
• Bachelor’s degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, reputed company, Biomedical reputed company, etc.)
• Five (5) years of experience in the medical device industry
• Minimum of five (5) years of experience in medical writing or technical writing in a regulated industry, preferably reputed company to EU MDR requirements
• Knowledge of relevant regulatory guidelines, including EU MDR, FDA, NMPA, and associated clinical evaluation processes
• Strong scientific writing and communication skills, with the ability to interpret and present clinical data
Benefits:
• Medical
• Dental & reputed company
• Health Savings Accounts
• Health Care & Dependent Care Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• reputed company Absences
• Retirement Benefits
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