HireDiversity

Irvine, CA, US

Director, Regulatory Affairs, ASP-6040120926

Description

Advanced Sterilization Products (ASP), a Division of Johnson & Johnson's Global Medical Solutions Group is recruiting for a Director, Regulatory Affairs, located in Irvine, CA.

ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.

ASP has created a new Board Level Position: Director of Regulatory Affairs. The Director of Regulatory Affairs will report directly to the World Wide President and will function as the global head of Regulatory Affairs for the ASP.

Qualifications


A successful Director of Regulatory Affairs candidate will possess the following qualifications and skills: A Bachelor's Degree in a scientific discipline required. An advanced degree, (e.g., PhD, DrPH, MPH, MS, etc.) in relevant technical discipline, or comparable experience, is preferred. A successful candidate will possess both a US and Global mindset; experience in different markets, countries and business models with a strong track record of success is preferred. A minimum of 10 years of progressive experience in Regulatory Affairs leading all aspects of new product development submissions is required. Medical device or pharmaceutical manufacturing industry experience required. Experience must include substantial regulated research, interactions with regulatory authorities, and a substantial track record of professional leadership (government or professional society leadership roles).

A successful candidate will also preferably possess experience with product safety and health technology assessment. Experience driving results in strong, diverse and collaborative leadership teams preferred. Demonstrated success in managing the product regulatory cycle, from development through launch, both domestically and internationally, is preferred. Progressive leadership experience, including "hands-on" advanced regulatory strategy development and experience managing a global group is also preferred. Demonstrated expertise in the applied interpretation of world-wide regulatory standards preferred. Experience in utilizing innovative approaches to quality in a fast paced changing business environment is highly preferred. The ability to take franchise business strategies and translate into key drivers and metrics for the organization also preferred. The ability to effectively present complex information to employees and business unit management is preferred. The ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives required.

Knowledge of FDA and EU regulatory compliance for medical devices preferred.

Ability to shape external regulatory environment preferred. Demonstrated ability to effectively recruit, develop, manage and mentor associates to strengthen organizational capabilities is preferred.

This position is located in Irvine, CA.

The position requires up to 35% travel domestically and internationally.

If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies

Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)