Senior Specialist Regulatory Affairs
Senior Specialist Regulatory Affairs
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Job Description
Job Title: Senior Specialist Regulatory Affairs
Job Location: Secaucus NJ USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
This is a Remote opportunity
- 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.
- A minimum of 5 years experience in a regulated industry. Threefour 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)
LICENSECERTIFICATIONS
Regulatory Accreditation Certificate
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets
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Employment Type
Full Time
