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Manager, Regulatory Affairs
Manager, Regulatory Affairs
Date: May 24, 2023
Location: US-FL-Clearwater, Florida, US
Company: Bausch & Lomb
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
OBJECTIVES / PURPOSE OF JOB
The Surgical Regulatory Affairs Manager handles all regulatory development aspects for surgical devices. The position’s focus is on intraocular lenses. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities.
KEY ACTIVITIES / RESPONSIBILITIES
Responsibilities may include but are not limited to:
- Responsible for developing a global product regulatory strategy for surgical devices
- Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development
- Develop a product regulatory timeline aligned to Bausch & Lomb’s product development, with key regulatory milestone, and activities for agency filing
- Coordinate with the team on the development of product labels
- Ensure labeling content and product documentation is developed in accordance with regulatory requirements
- Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
- Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory Authorities
- Act as a regulatory contact for assigned country Regulatory Authorities for surgical devices
- Liaise with Bausch & Lomb country-specific surgical Regulatory Affairs personnel for international submissions and registrations
- Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections
- Provide regulatory guidance/input to surgical device change control and internal product review boards
- Manage assigned personnel
- Other job responsibilities as needed.
QUALIFICATIONS / TRAINING
- Knowledge of 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 that affect assigned devices
- Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
- Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices
- Ability to influence and partner with cross-functional teams in a global surgical organization
- Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
- Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
- Demonstrated ability in analytical reasoning and critical thinking skills
- Strong capability to contribute and lead a team environment
- 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
- Bachelors degree in science or health related field
- Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)
- 8+ years relevant medical device industry and regulatory experience
- Ophthalmic Surgical device regulatory experience highly preferred
This position may be available in the following location(s): US – Remote
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch+Lomb’s Job Offer Fraud Statement.
Our Benefit Programs: https://www.bausch.com/careers/benefits/
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Job posted: 2023-05-24