Manager, MDR & Safety Operations
- Duluth, GA
• Collaborates with Safety Data Science to define and gather the relevant safety data outputs from global complaint management system.
• Analyzes and presents safety data for Alcon products at Post-Production Risk Reviews on behalf of Global Medical Safety.
• Coordinates with cross-functional subject matter experts to author post-market surveillance plans and aggregate safety reports (Device Periodic Safety Updates and Post-Market Surveillance Reports) with minimal supervisory guidance.
• Coordinates with R&D Risk Management Team in providing safety updates for Clinical Evaluation Reports, Post-Market Clinical Follow-up, Risk Management Files, and product labelling.
• Collaborates with Medical Safety franchises and business partners to monitor the safety profile of newly launched products emerging from aggregate reporting or large data set analyses.
• Prepare safety document templates and standard operating procedures in accordance with new or changing regulations.
• Collaborates with Medical Safety sub-functions to optimize operational efficiency in post-marketing surveillance activities; facilitates creation or updates of related internal or cross-functional standard operating procedures.
• Provides training on emerging medical device regulations and internal processes.
• May function as a deputy in Medical Safety franchise activities or special assignments if clinically/medically qualified.
• Number of and timely delivery of high quality safety documents to internal and external stakeholders.
• Development of processes and templates for safety documents as required by medical device regulations; driving initiatives for continuous improvements as applicable.
• Sharing of best practices and lessons learned from emerging medical device regulations.
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 [email protected] and let us know the nature of your request and your contact information. Equal Employment Opportunity Posters: If you'd like to view a copy of the Alcon's affirmative action plan or policy statement, please email [email protected]
Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not 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.
• Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc. +9 yrs; M.S. +2yrs; PhD +1yr)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of relevant Experience
• MD or OD is essential for associates performing medical review of single case reports.
• 5 of relevant experience, preferably in medical device safety, clinical research, or regulatory affairs.
• Clinical knowledge of ocular anatomy, common ocular conditions / diseases, and ophthalmic treatments or surgical procedures.
• Proven ability to analyze, interpret, and discuss safety information relating to multiple therapeutic areas.
• Prior experience in scientific / technical writing of device technical files.
• Solid interpersonal, communication (written and verbal), and presentation skills.
• Experience with (safety or others) issue management.
• Ability to work independently and meet targeted timelines in a team-centric environment.
• Ability to work under pressure, demonstrating initiative and flexibility
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