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 years of medical device regulatory experience with a Bachelor's degree or 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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