17 Regulatory Affairs Specialist Jobs in North Chicago, IL
Katalyst Healthcares & Life Sciences is Hiring a Regulatory Affairs Specialist Near North Chicago, IL
- Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
- Creates, reviews, and approves engineering changes.
- Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
- Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission database and file systems.
- Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel May interface directly with FDA and other regulatory agencies.
- Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
- Reviews protocols and reports to support regulatory submissions.
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Bachelor's degree or an equivalent combination of education and work experience
- Minimum 3 years' related experience including a minimum of two years regulatory experience.
- Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to leverage, manage and/or engage others to accomplish projects.
- Multitasks, prioritizes, and meets deadlines in a timely manner.
Job Summary
Contractor
$81k-105k (estimate)
03/29/2024
07/17/2024
katalysthls.com
South Plainfield, NJ
<25
Related Companies
The job skills required for Regulatory Affairs Specialist include Collaboration, Initiative, Written Communication, Communicates Effectively, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist, it can be promoted into senior positions as a Regulatory Affairs Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Specialist. You can explore the career advancement for a Regulatory Affairs Specialist below and select your interested title to get hiring information.
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