Sr. Regulatory Affairs Specialist

Responsibilities:Develop strategies for worldwide product registration with global regulatory agencies.Provide regulatory advice, preparing worldwide submissions, negotiating approvals, and assisting with license maintenance, including renewals and manufacturing site registrations.Author and prepare regulatory submissions for new products and changes.Review significant regulatory issues with supervisors and resolve submission issues.Develop regulatory strategies and provide ongoing support to project teams.Maintain regulatory support for marketed products and prepare necessary submissions.Negotiate with regulatory agencies as needed.Participate in project team meetings to plan strategies and define target markets.Maintain Regulatory Affairs product files to support compliance.Provide training and support to department members.Stay current on global directives and communicate changes affecting cross-functional areas.Requirements:Bachelor's degree in a technical discipline.Master of Science Degree preferred but not required.Minimum of 5 years of medical device regulatory experience with a Bachelor's degree or 3 years with an advanced degree.Strong negotiation and communication skills (both written and oral).Organizational and time management skills.Ability to manage multiple projects and meet deadlines.Proficiency in MS Office, MS Project, Adobe Acrobat, and Agile.In-depth experience with FDA requirements, guidance documents, and global regulatory standards.History of successful device submissions.Experience working in a regulated environment with cross-functional project teams.

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