8/1/23 Nadine - We just spoke with the hiring manager, and he updated the role with the below notes.
Need to understand the process to commercialize and go to market with a new assay.
Understands the purpose of a design control.
Understand the process of going to a clinical trial and the documents needed.
Understand the regulations and requirements around submitting a device to an agency in EU, UK, and rest of world.
Knows what doing a submission to the FDA really means.
Need experience submitting an IDE to the FDA.
The process of asking the FDA for permission to do a clinical trial.
Process of going to clinical trial
What is an SRD?
Understands 5 10 K PMA
Know how to execute an IDE and experience submitting IDEs. What do you submit an IDE for? Purpose behind the documentation. What are you asking the FDA to do?
Testing an assay and developing an assay according to FDA CFR Part 820.

Must have Assay development.
IDE for clinical
PMA which Premarket Authorization
FDA Submission
An assay is an investigative (analytic) procedure in laboratory medicine, mining, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity (the analyte).Our Client, An American clinical laboratory, is seeking a Regulatory Affairs Specialist II
Location: Remote
Position Type: IT Full Time
Job Summary:
With minimal supervision, responsible for coordination and preparation of document packages for regulatory submissions from all areas of the company. Compiles all materials required for submissions, license renewals and annual registrations to ensure the sale ability of Client products domestically (United States) and internationally (EU/Canada/ROW). Reviews and recommends changes for labeling, marketing literature and clinical protocols for regulatory compliance to international/recognized standards and procedures. Keeps abreast of all regulatory registration regulations, approval processes, standards and changes. Participates in the interactions with representatives from the Food and Drug Administration (FDA), Authorized Representative, Competent Authorities, Notified Bodies and other regulatory agencies on defined matters to achieve approval to sell Client products. Recommends strategies for earliest possible approvals of products. Maintains a library of standards, guidance documents.
Job Responsibilities:
Participate on project teams as regulatory or as RA/QA/CA representative.
Develop plans to receive approvals to sell products identified in the marketing sales plan.
Maintain knowledge and information of requirements to market products domestically and in all countries outside the U.S.
Timely preparation of regulatory submissions to the FDA, international dossiers/technical files required for CE Mark for EU countries and other international product registration files as required for ROW distribution.
Interacts with representatives from the Food and Drug Administration (FDA), Notified Body, Authorized Representative and other regulatory agencies to resolve issues or questions in the applications.
Maintain a library and knowledge of current standards and guidance documents as information reference for use by the organization.
Reviews product changes to determine if these changes affect product labeling and/or product registration/submissions.
Skills and Experience:
with a minimum of 5 years experience in a regulated industry. Three-four years regulatory submissions work in domestic/international registrations and IVDR experience required.
Experience with IVDR/ IVD PMA submissions preferred.
LANGUAGE SKILLS: Ability to read and analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from employees, managers, vendors or customers. Ability to effectively communicate plans, issues and resolve problems/conflicts in a project team setting.
MATHEMATICAL SKILLS: Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.
REASONING ABILITY: Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to handle multiple projects and prioritize tasks/deliverables. Ability to interpret a variety of instructions furnished in written oral, diagram, or schedule form.
EDUCATION: Bachelor's Degree(Required), Master's Degree.
Salary Range: $100,000 - $120,000