GRA Device Lead – Associate Director

GRA Device Lead – Associate Director

Requirements

• Understanding of and experience with global regulatory requirements for in-vitro diagnostics and technical/industry standards related to clinical laboratory requirements
• Basic understanding of regulations and guidelines related to drug development and registration is required
• M.S. degree –in a scientific or engineering discipline –with 6 years regulatory experience, or B.S. with 8 years regulatory experience
• At least 3 years of relevant diagnostics regulatory experience required
• At least 10 years in the global healthcare industry
• Proven experience with in-vitro diagnostics regulatory strategies and approvals
• Ability to synthesize and critically analyze data from multiple sources
• Dynamic personality, ability to think outside the box
• Demonstrates excellent communication and influencing skills internally and externally and in particular the ability to impact and influence decisions on global teams, both written and verbal, in English
• Strong interpersonal skills and the ability to deal effectively with a variety of business areas including medical, scientific, and manufacturing staff
• Demonstrate strong organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities including the ability to prioritize workload and capacity to work under pressure
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
• Independently motivated, detail oriented and good problem-solving ability
• Ability to travel internationally

Responsibilities

• Serve as GRA-Devices lead on assigned project teams (early phase, late stage and marketed products), supporting diagnostics device aspects
• Develop innovative and sustainable medical device regulatory strategies covering diagnostic (device elements)
• Prepare regulatory design control deliverables
• Review design control deliverables
• Lead and/or support global filing activities for diagnostics and diagnostics aspects of medicinal product submissions
• Support device related health authority interactions
• Provide regulatory impact assessments for proposed product changes
• Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed
• Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted
• Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed
• Contribute to internal regulatory processes and procedures for diagnostics and medical devices
• Engage with the relevant regulatory bodies and industry groups to influence industry standards and regulations, ensuring that Sanofi’s best interests are represented.

Preferred Qualifications

• Ability to think outside the box
• Dynamic personality