At Alcon, we are driven by the meaningful work we do to help people see brilliantly.
We innovate boldly, champion progress, and act with speed as the global leader in eye care.
Here, you’ll be recognized for your commitment and contributions and see your career like never before.
Together, we go above and beyond to make an impact in the lives of our patients and customers.
We foster an inclusive culture and are looking for diverse, hardworking people to join Alcon As a Regulatory Affairs Manager supporting the Global Regulatory Affairs Team, you will be 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 in Fort Worth, TX or Lake Forest, CA.
In This Role, a Typical Day Will Include Developing global regulatory strategy for new product development.
Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports to support US, EU and Canada markets.
Interacting and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answer any questions Serving as a regulatory liaison on the project team throughout the product lifecycle.
Participating 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.
Providing support as needed for non-project related “regulatory excellence” activities.
Ensuring 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.
Driving superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
Key Performance Indicators Demonstrates ability to coordinate and work effectively with multiple stakeholders.
Ensures timely, clear communications to internal stakeholders on project status and issues.
Serves as role model and embraces corporate Values and Behaviors Demonstrates good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.
Meets individual goals as defined in the annual objectives.
Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks.
Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.
Strong writing skills in the form of high quality regulatory submission documents.
Commits to driving efficiency while maintaining quality.
Ability to prepare detailed and accurate documentation.
Must have the ability to work independently and meet deadlines on a multitude of concurrent tasks Must possess strong analytical skills and effectively work with internal and external customers, and function as a team player.
Performs and assumes other duties and responsibilities, as may be required.
What You’ll Bring To Alcon Bachelor’s Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD0 yrs) The ability to fluently read, write, understand and communicate in English 5 Years of Relevant Experience Work Hours: Exempt Travel Requirements: 0-5% Relocation Assistance: No Sponsorship Available: No Preferred Qualifications/Skills/Experience FDA medical device regulations and EU MDR experience.
Alcon is an Equal Opportunity Employer and participates in E-Verify.
Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitmentalcon.com and let us know the nature of your request and your contact information.