8 Jobs in Lincolnshire, IL
Sysmex America is Hiring a Manager, Regulatory Affairs Near Lincolnshire, IL
- to use your skills and experience.
- to improve the lives of others.
- to build a promising future.
Essential Duties and Responsibilities:
- Prepare, write and document submissions for FDA and Health Canada applications. Responds to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance.
- Review all regulatory materials to guarantee accuracy, timeliness, comprehensiveness, and compliance with regulatory standards.
- Core team member on project teams, providing regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Develop submission regulatory strategies and plans and provide guidance regarding regulatory requirements for device changes.
- Maintain regulatory affairs procedures to ensure regulatory compliance is sustained or enhanced as well as ensuring adherence to internal procedures.
- Maintain current knowledge of relevant regulations and guidelines including proposed and final rules for IVD products.
- Appy understanding of Design Controls, Risk management, Quality systems relating to risk and submission timing.
- Support post-approval products through change evaluation and submission and annual reporting as required.
- Review analytical and clinical study protocols for related IVD products.
- Other duties, as required.
Percentage of Travel: Minimal 5-10%
Qualifications
- Bachelor’s degree in science related field or equivalent required. Minimum 5 years of progressive experience in medical devices/IVD/biotech industry Regulatory Affairs required, including experience in Armed Forces.
- Medical Technology background or RAC qualification would be a plus.
- Experience working directly with regulatory agency representatives.
- Thorough understanding of FDA regulations and requirements for in vitro diagnostic devices.
- Thorough understanding of the 510(k) process and working knowledge of CLSI guidelines requirements.
- Hematology, Urinalysis, Flow Cytometry and Coagulation experience a plus.
- English
- Japanese would be a plus
- Excellent general IT skills i.e. Microsoft Office/Outlook etc.
- Ability to follow guidelines and effectively communicate scientific data in a clear manner.
- Ability to develop and maintain professional relationships with internal and external subject matter experts to obtain necessary support for product applications or submissions.
- Excellent communication skills, ability to communicate and work at all levels of the organization.
- Strong organizational skills and high attention to detail. Ability to deal with high stress situations is a must.
- Ability to work as part of a team.
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Job Summary
Full Time
Wholesale
$129k-171k (estimate)
05/26/2024
06/23/2024
sysmexmarketing.com
LINCOLNSHIRE, IL
500 - 1,000
2012
Private
JOHN KERSHAW
$200M - $500M
Wholesale
Related Companies
The job skills required for Manager, Regulatory Affairs include Regulatory Affairs, Regulatory Compliance, Communication Skills, Communicates Effectively, Microsoft Office, Organizational Skills, etc. Having related job skills and expertise will give you an advantage when applying to be a Manager, Regulatory Affairs. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Manager, Regulatory Affairs. Select any job title you are interested in and start to search job requirements.
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