Title: Surgical Global Regulatory Affairs Director
Location: United States-California-Aliso Viejo Site
The Global Regulatory Affairs Director manages all regulatory aspects of Bausch & Lomb’s Surgical products throughout their lifecycle. The position covers Equipment, Instruments and Accessories, IOLs, Inserters and Surgical Solutions.
The incumbent is responsible for the overarching global surgical regulatory strategy, and managing interactions with various regulatory authorities. Provides directional guidance to the business on how to prepare products for approval and keeps abreast of evolving global regulatory requirements. Leads Regulatory Affairs personnel associated with the Surgical product lifecycle (which includes but is not limited to Regulatory Product Development, Advertising and Promotion, Labeling, and evaluation of changes to product, process, facilities, etc.). Leads and develops personnel to promote compliance with all laws, regulations, or guidance. The position is responsible for regulatory activities related to design, development and US/EU approval.
Specific Job Duties :
Serve as a leadership team member for Bausch & Lomb’s Surgical Regulatory Affairs function
Oversee the development of global product regulatory strategies for all Bausch & Lomb Surgical products
Oversee the regulatory functions in relation to device design & development and product approvals, consistent with Bausch & Lomb agreed upon timelines
Manage interactions with Regulatory Authorities for Surgical products
Build relationships with regional and global Bausch & Lomb Regulatory Affairs teams
Provide regulatory support to other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections
Provide regulatory guidance/input to internal product review boards
Select, develop, and motivate a regulatory team that supports personal growth and a culture of compliance
Play a significant role in the performance management process and career development programs for supervised regulatory personnel
Education & Experience
Bachelors degree in science or health related field
Advanced degree highly preferred (PhD, MD, MS, JD, or equivalent)
10 years medical device industry and regulatory experience
Ophthalmic Surgical device regulatory experience highly preferred
Qualifications
Strong capability to lead and support a collaborative team environment
Demonstrated ability in analytical reasoning and critical thinking skills
Ability to manage in a highly matrix organization
Demonstrated ability to lead a multidisciplinary team
Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
Excellent communication skills; both oral and written
Strong interpersonal skills with the ability to influence others in a positive and effective manner
Demonstrated ability to contribute to a continuous learning and process improvement environment
Capacity to react quickly and decisively in unexpected situations
Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
Focused ability to influence operational excellence and performance metrics
Risk adverse where needed with the ability to identify potential solutions to complex problems
Technical Qualifications
Knowledge of ophthalmic surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations
Knowledge of domestic and international laws, regulations, and guidance
Knowledge of clinical development, including responsibilities for successful management of development milestones and global market authorization
Ability to influence and partner within Bausch & Lomb Global Regulatory Affairs group and with cross-functional teams
Ability to take innovative ideas and design a successful product regulatory strategy and, in so doing, increase probability of regulatory approval
Ability to support the product development team to assess whether technical arguments are presented clearly and conclusions are adequately supported by data
Managerial Responsibility 4Job: Regulatory Affairs
