THIS JOB CAN BE LOCATED IN FORT WORTH, TEXAS OR LAKE FOREST, CALIFORNIA OR JOHNS CREEK, GEORGIA - RELOCATION ASSISTANCE IS PROVIDED
Responsible for managing multiple cross functional teams (R&D, QA, MT, Supply Chain, IT) to transform Alcon’s products, procedures, processes to compliance with global medical devices regulations (+/- USD75M)
Negotiate with Regulatory Bodies on legislation interpretation, work with major trade associations to develop industry standards to secure the continuation of the business in the EU (USD 1.2 billion Revenue) and other affected countries.
Manage 20+ work streams across functions: R&D, MTO, Supply Chain, Quality, Regions, IT, to establish objectives for the teams, manage deliverables including accurate cost reporting and budget.
Develop and manage the education and communication on EU DMR requirements, actions and impact on a global basis, including senior leadership, external stakeholders, regulators and Notified Bodies.
Transform major processes like complaint handling, device lifecycle management, developing regulatory submission files, product labeling and implementation to ensure efficiency and minimal disruption for external customers.
Establish regular alignment and negotiation with the Notified Bodies TUV and BSI and other regulators on ongoing activities to ensure continued compliance to regulatory expectations.
Attend major industry meetings to interface with external customers, regulators and industry peers to gather related competitive intelligence on Alcon EU Medical Devices and influence EU Medical Devices regulations interpretations.
Provide appropriate customer and other external stakeholder feedback to R&D, MTO, Commercial, Supply Chain, etc. teams to ensure optimal execution of regulatory requirements.
Address concerns from regulators related to Alcon medical devices, develop regulatory strategies to ensure continued availability of Alcon devices for Alcon customers whilst meeting the expectations from regulators.
Bachelor’s degree with 10 years of directly related work experience in Regulatory Affairs, Quality, Manufacturing, Medical Affairs and/or R&D, including customer interfacing positions in the Medical Device industry OR equivalent combination of education and work experience (HS+18, AA+14, MS+7, PhD+6).
6 years of demonstrated leadership experience.
Proficient use of the English language, both oral and written.
Preferred Skill Set/Experiences
5+ years of experience in a medical device clinical setting.
7+ years of successfully leading people.
Proven successful performance in a global/matrix environment.
Proven capability to get results through people and influence across boundaries.
Additional Salary Information: This positon has a lucrative benefits package including a strong base salary, bonus potential, Long Term Incentive plan participation, full medical dental vision and 401K benefits with a strong match and employer contribution program.
Internal Number: 237043BR
About Alcon, A Novartis Division
As the global leader in eye care, Alcon develops and manufactures innovative medicines and devices to serve the full life cycle of eye care needs. We have one mission: to discover new ways to enhance sight and improve people’s lives. Together with Novartis, we offer the widest spectrum of products in eye care. This enables us to serve our customers through the full life cycle of patient needs across eye diseases, vision conditions and refractive errors. Our vision is to be the most trusted leader in eye care. By serving and working with people worldwide, we are building our reputation, while addressing the growing eye care demands of the future. At Alcon, we recognize that our success depends on the creativity, dedication and performance of our associates. That’s why we foster a performance-oriented culture that encourages achievement through collaboration and innovation. This culture is reflected in our product pipeline, one of the most exciting in the industry today. We depend on our diverse and talented associates to bring a full spectrum of innovative medicines and devices to patients that address their eye care needs, creating one of the most rewarding work environments in our industry.