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Regulatory Affairs Specialist II
2 months ago
We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Pyramid Consulting, Inc. in a contract position.
Job Summary:The successful candidate will support the IA business unit in meeting global registration requirements, interpreting federal/state/international regulations, and advising on compliance strategies.
Key Responsibilities:- Support global registration requirements and ensure compliance with regulations.
- Interpret federal/state/international regulations and advise on compliance strategies.
- Audit and evaluate current policies, procedures, and documentation for compliance.
- Determine the need for and prepares regulatory submissions.
- Respond to regulatory agency inquiries and communicate with internal technical and regulatory personnel.
- Write and edit technical documents, including IVDR and Global registration documentation.
- Monitor applications under regulatory review and maintain regulatory files.
- Update and maintain paper/electronic document archival systems.
- Determine product regulatory path or class and evaluate design changes for regulatory filing strategies.
- Assess regulatory impact and risk, and develop plans for timely renewal registrations.
- Bachelor's degree in Science, Regulatory Affairs, or Engineering, plus 3-5 years of experience in the offered position or related.
- Excellent organizational skills and attention to detail.
- Strong work ethic with an ability to work independently.
- Ability to interpret and apply regulations to company policies and procedures.
- Pragmatic with strong problem-solving skills and experience working with cross-functional product development teams.
Pyramid Consulting, Inc. is an equal employment opportunity employer and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
