Global Regulatory Intelligence, Senior Project Manager

Required

• Bachelor's degree in science, engineering or related field, with a minimum of 4 years of regulatory, quality, and/or compliance experience in medical device or biologics.
• Experience with FDA Class II or III devices or experience with EU Class IIa/IIb or III devices.
• Experience with interpretation and application of new regulations, legislation, standards or guidelines.
• Strong analytical, technical writing, communication, organizational, project management, time management and interpersonal relationship skills.
• Awareness of global regulatory affairs, product development and total product lifecycle processes.
• Strong ability to sift through complex information, discern high-quality data, and translate it into meaningful intelligence.
• Excellent verbal and written communication skills are essential for conveying complex regulatory topics to diverse internal audiences.
• Proficiency with regulatory intelligence databases and monitoring tools, and general office software.
• Strong attention to detail for accurately tracking and interpreting regulatory information.
• Experience working with cross-functional teams.
• Ability to comprehend principles of engineering, physiology, and medical device use.
• Ability to effectively manage and prioritize numerous projects and responsibilities.
• Strong analytical, technical writing, verbal/written communication, organizational, and time management skills.
• Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects.
• Project management experience.
• Ability to effectively manage and prioritize numerous projects in a fast-paced environment.
• Expertise in Microsoft Office Suite

1. 1The role will track, monitor, analyze, and interpret global regulatory developments (regulations, guidelines, standards and legislation) to ensure compliance and strategic decision-making within the organization.
2. 2Proactively identify, mitigate, and manage potential regulatory or compliance risks by staying ahead of upcoming changes and initiatives. Communicate new and upcoming changes. Facilitate and assist with interpretation to guide product and business compliance with regulatory requirements.
3. 3The role will assess impact to business operations and provide insights to functions and teams. Provide actionable insights to internal stakeholders. Drive internal review and implementation with Subject Matter Experts. Ensure projects and tasks meet business objectives and expectations.
4. 4Manage and utilize regulatory intelligence tools, databases, and other information resources to maintain a knowledge base and improve processes.
5. 5Maintain expert proficiency in worldwide regulatory requirements; establish and maintain advanced relationships with agency personnel and industry organizations. Collaborate with functional partners to implement regulatory changes to regulatory/compliance documentation and procedures. Drive issues to resolution.
6. 6Act as a Regulatory Subject Matter Expert (SME) on key topics and provide strategic guidance to regulatory affairs, functions, and cross-functional teams. Collaborate with quality, clinical, legal, and operations to align regulatory intelligence strategies.
7. 7Influences management on technical or business solutions related to regulatory intelligence. Develop network of internal partners and be a subject matter expert to ensure projects meet regulatory requirements.
8. 8Establish and maintain positive relationships with stakeholders and team members. Leverage experience and technical knowledge to advance corporate strategies.
9. 9Examine and recommend opportunities within industry to advance organizational objectives.
10. 10This position requires strong collaboration, communication, and analytical skills to support product development, market access, and post-market activities in alignment with global regulatory requirements.
11. 11The role involves using regulatory databases and specialized software. Train others in the use of regulatory systems and tools. Advise on process improvements and lead to completion, where assigned. Drive to solutions.
12. 12Communicate complex regulatory information clearly and concisely to various internal teams, such as product development, research, operations, and quality.
13. 13Lead complex technical projects with considerable initiative and independence, strategic and critical thinking, and effective decision-making skills, with the ability to prioritize and balance multiple competing priorities and escalate issues when critical risks arise. Advanced project management skills applied to all assignments.
14. 14May support regulatory submissions. Track and report the status of regulatory actions and submissions to internal stakeholders.
15. 15Participate in inspections, audits, and post-audit corrective actions.
16. 16Ensure understanding of all quality policy/system items, as applicable. Maintain and update regulatory processes and SOPs. Follow all work/quality procedures to ensure quality system compliance. Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.).