Key contributor in Integrated Resource Planning at Duke Energy. Prepare executives for regulatory testimonies on future energy demands and regulatory compliance.
About the role
- Provide regulatory support to ensure compliance and approvals for medical products. Assisting in global submission requirements and documentation management while executing regulatory strategies.
Responsibilities
- Provide regulatory support and expertise associated with US and global submission requirements, including analysis of the requirements and tracking of deliverables.
- With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers.
- Assures full regulatory compliance of all documentation for submissions and change management to enable product approval and issuance of EC certificates, FDA or other international certificates/permits/approvals.
- Ensure that key strategic new products are developed in line with the global registration requirements.
- Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.
- Plans and organizes registration packages for device products. Prepares registration packages in line with regional regulatory requirements and guidelines.
- With oversight, understand and respond to regulatory agencies or notified body correspondences.
- Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
- Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.
- Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
- Understand global regulations and assure regulatory compliance, minimizing development costs and cycles.
- Exercise good judgment within policy and regulations.
- Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.
- Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team.
- Reviews regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with manager prior to execution.
- Work on special projects as assigned
Requirements
- Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- RAC Certification preferred
- A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
- Able to assess scientific arguments and apply analytical and logical reasonings.
- Ability to effectively prioritize workload and multitask with minimal supervision.
- Good interpersonal skills.
- Good oral and written communications skills.
- Demonstrated project management skills.
- Demonstrated critical thinking, contingency planning and negotiating skills.
- Understanding regulatory and business needs with ability to engage cross functional team members.
- Demonstrated critical thinking, contingency planning and negotiating skills.
- Understanding of regulatory and business needs with ability to establish direction and influence cross functional team members.
Benefits
- Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
- A wide range of benefit options at affordable rates
- Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
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