1 Regulatory Affairs Specialist Job in Minnetonka, MN
Katalyst Healthcares & Life Sciences is Hiring a Regulatory Affairs Specialist Near Minnetonka, MN
- Interact with internal marketing, R&D, QA, and project managers to provide support to currently marketed products as necessary and for new product development. This includes reviewing labeling, product changes and documentation for changes requiring government approval.
- Coordinates and prepares document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Define the regulatory strategy and manage regulatory submission activities for change development activities and product maintenance for existing approved products.
- Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.
- Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
- Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- Recommends strategies for earliest possible approvals of clinical trials applications.
- Regulatory submission experience.
- Ability to effectively manage multiple projects and priorities.
- Experience with FDA and international regulatory agency requirements
- Experience working with medical device or pharmaceutical regulatory submissions.
- Familiarity with regulatory requirements in major international markets (China, Japan, Brazil, Canada, EU, Korea, etc.)
- RAPS certification (RAC)
- Working knowledge of IEC 60601-series standards
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
- Experience with 510(k)/IDE/PMA device product submissions and other worldwide submissions and clearances
- Experience with EU MDR
- Ability to comprehend principles of engineering, physiology and medical device use.
Job Summary
Contractor
$101k-129k (estimate)
02/11/2023
05/09/2024
katalysthls.com
South Plainfield, NJ
<25
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