Director, Regulatory Affairs
US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: CA - San Diego
As the Director of Regulatory Affairs, the responsibilities consist of leading an entire function for a sub-region or significant business unit; or leads a sub-function for a division or major region; or is a global leader for a major team. Develops policies and authorizes / guides their implementation.
- Oversees and directs all regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies.
- Creates and drives strategy for the area of responsibility with some operational and tactical responsibility.
- Regularly interacts with senior leadership, requiring negotiation and influence on critical policy-making decisions (internal and external).
- Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements.
- Regularly interacts with executives and/or major customers. Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization.
- Supervisory Responsibilities:
- Directs and controls the activities of a broad functional area through several department managers within the company. Has overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods.
- Requires strong leadership skills and clear, open, transparent communication skills
- Provide oversight and direction for US regulatory strategy and execution
- Provide oversight and direction for OUS regulatory strategy and execution
- Provide regulatory strategies in communication with research and development and marketing departments
- Oversight and guidance with respect to tissue regulatory compliance and new product development, including expansion of indications
- Minimum of 15 years of related experience with a Bachelor’s degree; or 12 years and a Master’s degree; or a PhD with 8 years experience; or equivalent experience.
- Medical Device experience, preferably in Spine
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.