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regulatory pm
1 month ago
regulatory pm.
minneapolis , minnesota (remote)
posted today
job details
summary
$70 - $80 per hour
contract
bachelor degree
category computer and mathematical occupations
reference1057813
job details
job summary:
Work independently on RA duties, processes and roles outlined below.
Sits on New Product Development Team for assigned products and provides
Regulatory analysis on the Product Development Plan
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.
Lead special regulatory projects and process improvement projects, including
developing project plans and monitoring progress and completion for regulatory
activities
Lead review for new and revised guidance's, regulations and standards
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.
Mentors Regulatory team members
Technical File creation, review, and approval
Design History File creation, review , and approval
Declaration of Conformity creation (MDD, MDR, RED,, RoHS, etc)
Regulatory assessment of Engineering Changes and Regulatory Assessment
Checklist completion
New Product Licensing and Registration submissions in the Domestic and
Mature Markets (US, EU, CAN, AU)
Create and/or lift Regulatory Restrictions based on the Regulatory status of
assigned products
German Reimbursement submissions
Provides document support to the Emerging Markets team for international
product registration
Reviews and approves product labeling plans, labels, and marketing
communications
Reviews Modified Product Applications for regulatory compliance
location: Minneapolis, Minnesota
job type: Contract
salary: $70 - 80 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
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: Experienced
Minimum 10 years of experience
Education: Bachelors (required)
skills:
ManagerEqual 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).This posting is open for thirty (30) days.
