Manager, Regulatory Affairs
Company: Bausch + Lomb
Location: Clearwater
Posted on: January 22, 2023
Job Description:
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 worldfrom 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
JOBThe 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 + Lombs 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.QUALIFICATIONS/
TRAINING
- 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.EXPERIENCETen (10) years of experience in Regulatory
Affairs or a Masters in Regulatory Affairs and 8 years of
experience#LI-CJ1This position may be available in the following
location(s): [[location_obj]]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
readBausch+Lomb's Job Offer Fraud Statement
(https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx)
.
Keywords: Bausch + Lomb, Clearwater , Manager, Regulatory Affairs, Executive , Clearwater, Florida
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