Global Regulatory Affairs Principal Specialist

Alcon; Lake Forest (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Alcon is seeking a Global Regulatory Affairs Principal Specialist to join the Regulatory Affairs team at Fort Worth, TX, Johns Creek, GA or Lake Forest, CA. You will develop global regulatory strategy for new product development and direct submission work for US, EU and Canada markets.

The role involves negotiating with regulatory agencies and providing strategic direction across the product lifecycle. You will act as regulatory liaison to project teams, ensure regulatory compliance for trial

Qualifications

• Bachelor's degree or equivalent years of directly related experience.
• 5 Years of Relevant Experience.
• English fluency (read, write, understand)

Responsibilities

• Develops global regulatory strategy for new product development.
• Directs submission development of product registrations and reports.
• Interacts with regulatory agency personnel to expedite approvals.
• Serves as regulatory liaison on project teams throughout the product lifecycle.
• Ensures regulatory requirements for pre-clinical and clinical designs are met.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory liaison

Project management

Education

Bachelor's degree

Associate degree

MS

PhD

Job description

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 in Fort Worth, TX, Johns Creek, GA or Lake Forest, CA location. 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, interacting and negotiating with regulatory agency personnel in order 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 in order 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 one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan.
• Ensuring pre-clinical and clinical trial designs meet regulatory requirements
• Ensuring rapid and timely approval of new medical devices and continued approved status of marketed medical devices
• Serving as regulatory representative to marketing or research project teams and government regulatory agencies.
• Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
• Coordinating, reviewing and potentially preparing reports for submission In some organizations, 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 track and support 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 intl.
• Relocation assistance: No
• Sponsorship available: No

Preferred Qualifications/skills Experience

• FDA medical device regulations and EU MDR experience preferred.