RESPONSIBILITIES:

• Contributing in developing embecta's regulatory policies, standards and strategy, the Director collaborates closely with the regional and R&D team to manage potential impact from regulatory changes.
• Collaborating with internal leaders across the organization (WW Quality Management, Operations, R&D, Medical Affairs)
• Providing interpretation of existing and emerging regulations - make recommendations for changes in quality systems, policies, or procedures.
• Establishing programs and policies for communicating with pertinent regulatory authorities.
• Approving plan(s) for the auditing of regulatory systems; establishing audit programs, review findings and corrective actions; supporting regional-initiated recalls.
• Leading the management of product registration approval applications for all products within the Regions.
• Participating in industry trade groups to influence industry positions that may impact the regulatory compliance environment.
• EC Authorized Representative in the Regions.
• Retain and develop personnel to support business needs.
• Represent RA and demonstrate leadership in sophisticated product development teams by identifying and interpreting requirements and providing meaningful mentorship throughout the product development cycle prior to regulatory submission.
• Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to partners.
• Support development and execution of global strategies by collaborating closely with international associates to register our devices worldwide.
• Lead regulatory efforts required to align with new regulations (e.g., EU MDR, MDSAP) and requirements including changes to international standards.
• Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
• Represent embecta in relevant external trade organizations and regulatory standard's development as vital to support embecta continuous product development and compliance efforts.
• Remain current on regulations affecting embecta products (EU MDR etc.) and keep the relevant team and supervisors advised about potential impact.
• Identify ways to improve the efficiency of current work process and implement them.
• Carry out the above tasks with limited supervision.

EXPERIENCE & EDUCATION:

• B.S. or B.A. degree in a technical subject area (e.g., engineering, biology, chemistry). Advanced degree preferred.
• Substantial experience of directly related professional regulatory in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields.
• Experience working with standalone software, software as medical device (SaMD), Artificial Intelligence, and Machine Learning
• Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
• Experience leading meetings and negotiating with Notified Bodies and other global Health Authorities.
• Proven success in the strategy development, preparation, and authoring of regulatory submissions.
• Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
• Strong communication (written, oral) and project management skills.
• Able to prioritize multiple challenging tasks with outstanding attention to detail.
• Strong critical thinking skills.
• Able to work independently to achieve objectives on or before schedule.
• Proven global perspective, customer focus, cross-functional collaboration and partnership skills.
• Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and MDR 2017/745.