HireDiversity

Santa Barbara, CA, US

DIRECTOR, REGULATORY AFFAIRS-8409121219

Description

Mentor Worldwide L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Regulatory Affairs to be located in Santa Barbara, CA.

Mentor is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.

The Director, Regulatory Affairs will be responsible for directing regulatory affairs associates in the breast implant new product development platform and all Mentor products global re-registration activities in order to ensure that products, services and communications meet global regulatory requirements. The Director serves as chief contact and spokesperson for communication with global regulatory agencies and ensures that all company policies, procedures and practices are in compliance with appropriate regulatory requirements. The Director provides sound regulatory guidance and oversight to research, product development, and manufacturing organizations. The Director also provides guidance on legal and regulatory issues related to advertising, labeling, public disclosures, corporate communications, and other public relations activities. This position will require strong collaboration and partnering with medical affairs, clinical affairs, and quality compliance to assure a consistent regulatory approach for mentor with global regulators. This position will participate in new business development activities and audits as necessary.

The Director, Regulatory Affairs assures timely regulatory clearances for key product launches. The Director will have several direct reports and develop and implement a strategic vision and tactical plan consistent with franchise, business units and RA strategic objectives. The Director provides guidance to direct reports for the preparation and compilation of regulatory submissions for assigned projects consistent with established regulatory policies. The Director provides leadership, personnel development, training, coaching, and mentoring for staff. The Director builds relationships and systems to better support registrations outside the EU and United States. Determines and develops regulatory competencies and skills needed for the future success. Identifies potential successor/s and builds regulatory career ladder.

Qualifications


A Bachelor's degree and a minimum of 10 years of experience in regulatory affairs is required. A Bachelor's degree is a scientific discipline and an advanced degree / RAC is desirable. Global regulatory affairs and compliance experience is required. Direct experience with global regulatory submissions is required. Direct experience working on clinical trial and IDE is preferred. Proven leadership and strong people management skills are required. Experience managing regulatory affairs in a multi-site organization is preferred. A successful track record of coordinating and interacting with multiple cross-functional teams is required. Successful experience taking a product through the development and regulatory cycle both domestically and internationally is required. Excellent oral and written communication skills are required. Up to approximately 25% international and domestic travel may be required. This position will be located in Santa Barbara, CA.

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-Santa Barbara
Organization: Mentor Worldwide LLC (6177)