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Sr. Manager Product Certification

8+ years
Not Disclosed
10 Dec. 25, 2024
Job Description
Job Type: Full Time Education: BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Sr. Manager, Product Certification at Alcon

Alcon is seeking a Sr. Manager for Product Certification to ensure the safety and compliance of medical devices through rigorous testing and certification processes.

Core Responsibilities:

  • Safety Certification: Perform safety certification assessments throughout the product development lifecycle, from early stages to final testing, ensuring all safety requirements are met.
  • Support R&D: Collaborate with R&D teams to communicate status updates, risks, and propose solutions during product development.
  • Safety Testing: Conduct safety testing of Alcon products in both internal and external labs, including dielectric and leakage current testing, as well as construction evaluation.
  • Documentation: Prepare necessary documents for safety certification activities, including isolation diagrams and test reports, ensuring compliance with medical device standards.
  • Collaboration: Work closely with internal/external labs, technicians, and design engineers to ensure timely and cost-effective results.
  • Product Compliance: Ensure the product meets all required safety and certification standards (ISO 13485, QSR, IEC standards) and is ready for global market access.
  • V&V Testing: Document and execute verification and validation tests in compliance with medical device standards, ensuring the product is ready for launch.
  • Risk Management: Utilize ISO 14971 risk management principles for medical device safety compliance.

Role Requirements:

  1. Education & Experience:
    • BS in Electrical Engineering (or similar) with 8+ years of experience in medical device product safety compliance and certification evaluations.
    • Experience in working with accredited test labs such as UL, CSA, Intertek, or Element is a plus.
  2. Expert Knowledge:
    • Deep understanding of IEC 60601-1 (3rd Ed), IEC 60601-1-2 standards, and their application to electro-mechanical medical devices.
  3. Cross-Functional Leadership: Proven experience in leading cross-functional teams to manage the entire certification process and ensure compliance.

Internal Applicants:

If you are an active employee or contingent worker at Alcon, please apply through the appropriate internal career site:

Equal Opportunity Employer:

Alcon is an Equal Opportunity Employer committed to maintaining a diverse environment. We do not discriminate based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.


This position offers an excellent opportunity to play a critical role in ensuring Alcon’s medical devices meet the highest standards of safety and compliance for global markets.