| Immediate hiring for Regulatory Affairs specialist - Minneapolis, MN at Minneapolis, Minnesota, USA |
| Email: suzanne.rogers@concorditsystems.com |
|
https://jobs.nvoids.com/job_details.jsp?id=469593&uid= From: Suzanne Rogers, Concord IT Systems suzanne.rogers@concorditsystems.com Reply to: suzanne.rogers@concorditsystems.com Hello Hope you are doing good. Job Title: Regulatory Affairs specialist Location: Minneapolis, MN(Locals Only) Duration: Long term Job Description: Define the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products. Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory team to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare regulatory (e.g., FDA/Notified Body) submissions for new products and product changes, as required, to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager. Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. Provide business and product information to international regulatory team to enable development of strategies and requirements and communicate that information to business teams. Provide feedback and on-going support to product development teams for regulatory issues and questions. Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work. Nice to Have: Advanced degree in a scientific discipline (engineering, physical/biological or health sciences). Proficiency in assessing changes to labeling, design, materials and manufacturing for impact to US and EU requirements Experience with 510(k)/IDE/PMA device product submissions and EU regulations (MDR Knowledge in geography specific regulatory requirements for medical devices (APAC, LATAM, EMEA, Canada, China, Russia.) Experience performing advertising and promotion reviews for medical devices. Experience with FDA and international regulatory agency requirements Effective interpersonal skills. Effective team member. Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills. Ability to effectively manage multiple projects and priorities. Proficient computer skills. Project management skills. Excellent oral and written skills. Excellent analytical thinking skills. -- Thanks and Regards, Suzanne Rogers US IT Recruiter Cell : (312) 585-2508 Desk No.: 17866280721 Email Id: suzanne.rogers@concorditsystems.com Keywords: information technology Idaho Minnesota https://jobs.nvoids.com/job_details.jsp?id=469593&uid= |
| suzanne.rogers@concorditsystems.com View All |
| 07:30 PM 01-Aug-23 |