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Regulatory Affairs Specialist

at Northwestern Memorial Healthcare in Chicago, Illinois, United States

Job Description

Location Chicago, Illinois
Business Unit Northwestern Medicine Corporate
Job REQID 117950
Job Function Supply Chain
Shift Day Job (1st)

 

Benefits
$10,000 Tuition Reimbursement per year ($5,700 part-time)
$10,000 Student Loan Repayment ($5,000 part-time)
$1,000 Professional Development per year ($500 part-time)
$250 Wellbeing Fund per year($125 for part-time)
Matching 401(k)
Excellent medical, dental and vision coverage
Life insurance
Annual Employee Salary Increase and Incentive Bonus
Paid time off and Holiday pay
Pay Starting at: $34.16+ per hour based on experience
Northwestern Medicine is powered by a community of colleagues who are purpose-driven and committed to our mission to deliver world-class care. Here, you'll work alongside some of the best clinical talent in the nation leading the way in medical innovation and breakthrough research with Northwestern University Feinberg School of Medicine.
We recognize where you've been, and we support where you're headed. We celebrate diverse perspectives and experiences, which fuel our commitment to equity and culture of service.
Grow your career with comprehensive training and development opportunities, mentorship programs, educational support and student loan repayment.
Create the life you envision for yourself with flexible work options, a Reimbursable Well-Being Fund and a Total Rewards package that support your physical, mental, emotional and financial well-being.
Make a difference through volunteer opportunities we offer in local communities and drive inclusive change through our workforce-led resource groups.
From discovery to delivery, come help us shape the future of medicine.
Description
The Regulatory Affairs Specialist reflects the mission, vision, and values of NM, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards. Responsible for the coordination of procurement services the hospital with regards to procurement, processing and distribution of materials and services. This system should meet or exceed the requirements of the hospital and be accomplished at the most favorable cost.

Responsibilities:
Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.
Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Assist in preparation and review of regulatory submission to authorities.
Maintain annual licenses, registrations, listings and patent information.
Assist with product post-marketing approval requirements. Assist in the review of advertising and promotional materials.
Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.
Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.
With oversight, serves as a liaison with regulatory agencies pertaining to assigned products.
Assists in the preparation of agency meeting packages and strategies for agency meetings.
Evaluates manufacturing and labeling changes for regulatory impact.
Accurately describes these changes for ease of regulatory agency review.
Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.
Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
Interpret global regulations and assure regulatory compliance, minimizing development costs and cycles.
Define and negotiate regulatory strategy with supervision.
Responsible for tracking and completion of assigned registration activities.
Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.
Provides daily regulatory support to new product... For full info follow application link.

Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability or sexual orientation.

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Job Posting: 11930253

Posted On: May 26, 2024

Updated On: Jun 25, 2024

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