Manager – Regulatory Affairs
Job Description:
• Lead as the RA representative on project core teams providing active 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.
• Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions.
Requirements:
• Bachelor’s degree in a science-related 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 Point, Excel, Visio, Outlook and Project.
Benefits:
• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development
Apply tot his job
Apply To this Job
• Lead as the RA representative on project core teams providing active 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.
• Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions.
Requirements:
• Bachelor’s degree in a science-related 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 Point, Excel, Visio, Outlook and Project.
Benefits:
• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development
Apply tot his job
Apply To this Job