Overview Johnson & Johnson MedTech – Neurovascular Division is seeking an Associate Director for Scientific Operations. The preferred location for this role is Irvine, California or Galway, Ireland. We are accepting remote candidates within the United States and Europe. This is a remote role available in several countries. While specific cities are listed in the Locations section for reference, they are examples only and do not limit your application. We invite candidates from any location to apply.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Responsibilities Lead a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and when applicable manage submissions to the Notified Body.
Partner with R&D, Medical Affairs, Clinical, and Regulatory in the establishment of appropriate routes of conformity for clinical evaluations for new products introductions and product design changes and ensure robust data sufficiency strategies.
Develop and track performance and compliance metrics providing visibility to progress and rising challenges, enabling risk mitigation, corrective and preventive action to be taken as needed.
Track and trend Notified Body inquiries within the business unit to identify trends, improve processes, and increase speed to market. Translate insights into viable processes and solutions that create value.
Be a member of the MedTech Scientific Operations SOP committee responsible for the effective optimization and harmonization of processes across all MedTech franchises, supporting gap assessments against new regulations, and facilitating implementation plans.
Generate materials, lead workshops, and deliver training to ensure adequate implementation of guidelines and contribute to the professional development of employees.
Manage budget and all financial business processes.
Qualifications Required
Minimum of a Bachelor’s degree (University Degree), in Life Sciences, Engineering or related subject area.
Minimum of 8 years of experience in a regulated environment including five years of direct experience with medical devices in the fields of technical or medical writing, post market surveillance, clinical research, or product risk management.
Minimum of 2 years of people leadership experience.
Preferred
Knowledge on physiology and common outcomes of neurovascular diseases and events
An advanced degree, MS, PhD, RN, or MBA.
Process Excellence / Six Sigma training or certifications.
Employment type Full-time
Job function Management and Manufacturing
Hospitals and Health Care
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