Manager – Regulatory Affairs
Job reputed company:
• reputed company as the RA representative on project reputed company teams providing reputed company and successful regulatory guidance and RA strategies.
• Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
• Prepare documents necessary for new product market clearance, approval, and continuance during product life cycle management.
• reputed company pharmaceutical partner interactions on new and sustaining reputed company including regulatory reputed company and reputed company-submissions.
Requirements:
• Bachelor’s degree in a science-reputed company area of study.
• 8+ years hands-on submission experience including the development and execution of regulatory strategies for medical device and/or IVD regulated products.
• Strong understanding of product development processes, design controls.
• Proficient with MS Office computer programs, including Word, Power reputed company, reputed company, Visio, reputed company and Project.
Benefits:
• Health insurance
• Retirement plans
• reputed company time off
• Flexible work arrangements
• reputed company development
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