Alcon
Global Regulatory Affairs Principal Specialist
Alcon, Johns Creek, Georgia, United States,
Job Title:
Global Regulatory Affairs Principal Specialist
Location:
Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA
Summary of Position:Alcon is looking to hire a
Global Regulatory Affairs Principal Specialist
to join our
Regulatory Affairs
team. You will be responsible for developing global regulatory strategy for new product development, directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports, providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies, and interacting with regulatory agency personnel to expedite approval of pending registration and answer any questions.
Key Responsibilities:Develops global regulatory strategy for new product development.
Directs submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports to support US, EU, and Canada markets.
Interacts and negotiates with regulatory agency personnel to expedite approval of pending registration and answer any questions.
Serves as a regulatory liaison on the project team throughout the product lifecycle.
Participates in activities such as development of product plans, regulatory strategy, risk management, and implementation plans.
Ensures pre-clinical and clinical trial designs meet regulatory requirements.
Ensures rapid and timely approval of new medical devices and continued approved status of marketed medical devices.
Serves as regulatory representative to marketing or research project teams and government regulatory agencies.
Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, and appropriate regulations and interpretations.
Coordinates, reviews, and potentially prepares reports for submission. May coordinate and maintain reporting schedules for new medical devices and marketed products notices.
Provides support as needed for non-project related "regulatory excellence" activities.
Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes.
In a timely manner, provides solutions to a range of regulatory issues and has the freedom to act independently to execute.
Proactively tracks and supports regulatory intelligence activities related to the Alcon medical device portfolio.
Drives superior results by taking initiative, planning and implementing projects, setting priorities, and holding self and others accountable to meet commitments.
Key Requirements/Minimum Requirements:Bachelor's Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc. +9 yrs; M.S. +2 yrs; PhD +0 yrs).
The ability to fluently read, write, understand, and communicate in English.
5 years of relevant experience.
Work hours: 40 hours.
Travel Requirements: 10% domestic or international.
Relocation assistance: No.
Sponsorship available: No.
Preferred Qualifications/Skills Experience:FDA medical device regulations and EU MDR experience preferred.
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Global Regulatory Affairs Principal Specialist
Location:
Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA
Summary of Position:Alcon is looking to hire a
Global Regulatory Affairs Principal Specialist
to join our
Regulatory Affairs
team. You will be responsible for developing global regulatory strategy for new product development, directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports, providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies, and interacting with regulatory agency personnel to expedite approval of pending registration and answer any questions.
Key Responsibilities:Develops global regulatory strategy for new product development.
Directs submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports to support US, EU, and Canada markets.
Interacts and negotiates with regulatory agency personnel to expedite approval of pending registration and answer any questions.
Serves as a regulatory liaison on the project team throughout the product lifecycle.
Participates in activities such as development of product plans, regulatory strategy, risk management, and implementation plans.
Ensures pre-clinical and clinical trial designs meet regulatory requirements.
Ensures rapid and timely approval of new medical devices and continued approved status of marketed medical devices.
Serves as regulatory representative to marketing or research project teams and government regulatory agencies.
Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, and appropriate regulations and interpretations.
Coordinates, reviews, and potentially prepares reports for submission. May coordinate and maintain reporting schedules for new medical devices and marketed products notices.
Provides support as needed for non-project related "regulatory excellence" activities.
Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes.
In a timely manner, provides solutions to a range of regulatory issues and has the freedom to act independently to execute.
Proactively tracks and supports regulatory intelligence activities related to the Alcon medical device portfolio.
Drives superior results by taking initiative, planning and implementing projects, setting priorities, and holding self and others accountable to meet commitments.
Key Requirements/Minimum Requirements:Bachelor's Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc. +9 yrs; M.S. +2 yrs; PhD +0 yrs).
The ability to fluently read, write, understand, and communicate in English.
5 years of relevant experience.
Work hours: 40 hours.
Travel Requirements: 10% domestic or international.
Relocation assistance: No.
Sponsorship available: No.
Preferred Qualifications/Skills Experience:FDA medical device regulations and EU MDR experience preferred.
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