ICONMA
Responsibilities
Provide pre-market and post-market regulatory strategy to ensure regulatory compliance. Represent Regulatory on core teams providing regulatory feedback and guidance.
Developing validation and regulatory strategies for multiple IVD products, including Clinical Trial Assays (CTAs) and Companion Diagnostics (CDx).
Requirements
Looking for someone with at least 5 years direct relevant PMA experience.
Hands‑on experience with authoring, drafting and submitting all modules for a medical device (IVD) PMA – experience with tissues is desired.
Demonstrated experience working cross‑functionally to gather information and collaborate on submission documents.
Why Should You Apply?
Health Benefits
Referral Program
Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
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Developing validation and regulatory strategies for multiple IVD products, including Clinical Trial Assays (CTAs) and Companion Diagnostics (CDx).
Requirements
Looking for someone with at least 5 years direct relevant PMA experience.
Hands‑on experience with authoring, drafting and submitting all modules for a medical device (IVD) PMA – experience with tissues is desired.
Demonstrated experience working cross‑functionally to gather information and collaborate on submission documents.
Why Should You Apply?
Health Benefits
Referral Program
Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
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