job summary: Work independently on RA duties, processes and roles outlined below. 1. Sits on New Product Development Team for assigned products and provides Regulatory analysis on the Product Development Plan 2. Lead Project teams for Regulatory Projects with Business Unit Impact, to include the management of project team personnel, the development of an executable Quality Plan, coordination with partnering functions/departments/resources and the management of the associated schedule and budget. 3. Lead special regulatory projects and process improvement projects, including developing project plans and monitoring progress and completion for regulatory activities 4. Lead review for new and revised guidance's, regulations and standards 5. Creation and execution of Regulatory Strategies and Plans for assigned products in the Domestic, Mature, and Emerging Markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers. 6. Mentors Regulatory team members 7. Technical File creation, review, and approval 8. Design History File creation, review , and approval 9. Declaration of Conformity creation (MDD, MDR, RED,, RoHS, etc) 10. Regulatory assessment of Engineering Changes and Regulatory Assessment Checklist completion 11. New Product Licensing and Registration submissions in the Domestic and Mature Markets (US, EU, CAN, AU) 12. Create and/or lift Regulatory Restrictions based on the Regulatory status of assigned products 13. German Reimbursement submissions 14. Provides document support to the Emerging Markets team for international product registration 15. Reviews and approves product labeling plans, labels, and marketing communications 16. Reviews Modified Product Applications for regulatory compliance 17. Drafts Standards Requirements Document 18. Directly supports and interfaces Internal and External Quality Audits as a Subject Matter Expert 19. Addresses customer related concerns regarding the RA process for our products 20. Interfaces with Business Unit functions as needed to resolve regulatory concerns 21. Tracks pending domestic and global regulatory changes, develops and executes quality plans to minimize impact to the Business Unit 22. Maintains expertise in domestic and foreign regulations and standards, with a focus on assigned products and regional focus on the US (FDA), EU (MDD and/or MDR), CA (Health Canada), and AU (TGA). 23. Provides Regulatory Training to business units on regulations and standards as they apply to assigned products / business units. 24. Conducts Regulatory Intelligence Analysis on specific assigned regions or content and briefs the business unit Regulatory Teams on results. location: Minneapolis, Minnesota job type: Contract salary: $50 - 60 per hour work hours: 8am to 4pm education: Bachelors responsibilities: Qualifications: BA/BS degree.Working knowledge of appropriate global regulations, requirements, and standards.4+ years of related experience in a medical device or other regulated industry.PM to provide FDA Inspection Response Mgt PM oversee the management/maintenance of Power Audit PM to manage other CD FDA Comms qualifications: Experience level: ExperiencedMinimum 4 years of experienceEducation: Bachelors (required) skills: Project Coordination Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). Applications accepted on ongoing basis until filled.