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Manager, Regulatory Affairs
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 Global Regulatory Affairs (GRA), Medical Devices, Post-Market Sr. Manager will independently support all regulatory medical device initiatives for post-market/lifecycle management aspects of Bausch + Lomb’s respective product families. The Sr. Manager is responsible for implementing the regulatory post-market strategies of all submissions for products under their responsibility, as well as managing interactions with regulatory authorities on post-market issues.
KEY ACTIVITIES/ RESPONSIBILITIES
- Associate is responsible to follow requirements of applicable national and international regulations. Associate assists other Regulatory Associates in understanding how to interpret these regulations.
- Guides team in analyzing data received and preparing documentation for submission for the purpose of obtaining clearance and or approval for product.
- Participates on product design teams and verifies compliance with design control requirements and procedures.
- Determine appropriate regulatory requirements and strategies for company projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities.
- Acquire and maintain a current knowledge of federal (US, Canadian, and Europe) regulations pertaining to the lawful distribution of products which include facility registration, device listing, labeling and promotional review.
- Maintain documentation and a historical record for projects and provide management with updated product status.
- Participate in task force groups and industry working groups.
- Maintains current knowledge of Federal USA and Canadian regulations pertaining to legal distribution of medical products. Stays Company Confidential – Bausch + Lomb, Inc. abreast of FDA updates including new policies and guidance.
- Interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels.
- Assists external customers by supplying materials and documentation for US and foreign product registrations as well as certification of appropriate US commercialization status.
- Makes a proactive contribution to the overall Regulatory Affairs department growth. • Provides general regulatory consultation during absence of other associates.
- Participates in project performance team meetings on behalf of the business unit to provide ideas, methods, or processes for unit/company performance improvement.
- Develop global regulatory strategies for high-risk products and lead multidisciplinary project teams.
- Performs other job-related duties as assigned.
- 4-year degree in life sciences.
- Pre-IDE, pre-sub, IDE and/or PMA submission experience preferred.
- Must have completed three (3) 510(k) submissions and demonstrated ability to prepare submissions independently.
- Management experience (at least 5 years project or supervisory management).
- Demonstrated the ability to complete internal update (letters to file) preparations independently and completion of at least five (5).
- Demonstrate the ability to lead complex projects that may include clinical studies.
- Experience on Design Control project teams.
- Advanced ability for independent work, teamwork, and decision making.
- Demonstrated the ability to lead and mentor RA associates regardless of location.
- Demonstrated the ability to make correct decisions based on interpretations of federal laws, which in many instances are very general in nature to accommodate a variety of industries. These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues.
- Demonstrated the ability to develop global regulatory strategies for high risk products and lead multidisciplinary project teams.
Ten (10) years of experience in Regulatory Affairs or a Masters in Regulatory Affairs and 8 years of experience
This position may be available in the following location(s): US – Clearwater, FL
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.
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To learn more please read Bausch+Lomb’s Job Offer Fraud Statement.
Job posted: 2023-01-03