Alcon is looking for a Manager, MDR & Safety Operations to join our growing Safety team. This person will be managing four other people and will need to be located in Fort Worth, TX.
Job Purpose:
• Manage the coordination, preparation, and tracking of safety documentation for post-production lifecycle management of Alcon medical devices for Global Medical Safety
• Ensure that safety-related technical file documents are high quality and in compliance with standard operating procedures and global safety regulations
• Partner with Medical Safety franchises and Safety Data Science to optimize operational efficiencies within the organization
Responsibilities:
1. Collaborate with Safety Data Science to define and gather the relevant safety data outputs from global complaint management system.
2. Analyze and present safety data for Alcon products at Post-Production Risk Reviews on behalf of Global Medical Safety.
3. Coordinate 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).
4. Coordinate 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.
5. Collaborate 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.
6. Prepare safety document templates and standard operating procedures in accordance with new or changing regulations.
7. Collaborate with Medical Safety sub-functions to optimize operational efficiency in post-marketing surveillance activities; facilitate creation or updates of related internal or cross-functional standard operating procedures.
8. Provide training on emerging medical device regulations and internal processes.
9. Triage and facilitate audit/inspection questions regarding Global Medical Safety activities.
10. May function as a deputy in Medical Safety franchise activities or special assignments if clinically/medically qualified.
Preferred Qualifications:
Relevant industry or related field experience, preferably in medical device safety, clinical research, or regulatory affairs.
Key Requirements/Minimum Qualifications:
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: M-F, standard
Travel Requirements: 5-10%
Relocation assistance: No
Sponsorship available: No
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.
