Job 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 development teams and commercial support with guidance.
• Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
• Acts independently on all routine issues, makes judgment and executes.

Qualifications

Required

• Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering or medical fields is preferred.
• At least 4 years of relevant postgraduate experience.
• Software as a medical device (SaMD) experience

Preferred

• Master's degree
• Regulatory area is preferred but may consider quality assurance, research and
• development/support, scientific affairs, operations, or related area.
• Experience with Regulatory history, guidelines, policies, standards, practices, requirements and
• precedents; Regulatory agency structure, processes and key personnel.
• Principles and requirements of applicable product laws; Submission/registration types and
• requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising
• and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical
• guidelines of the regulatory profession, clinical research and regulatory process. Note: This
• knowledge may be developed through tenure in this position.
• Communicate effectively verbally and in writing. Communicate with diverse audiences and
• personnel. Write and edit technical documents.
• Work with cross-functional teams. Work with people from various disciplines and cultures.
• Write and edit technical documents.
• Negotiate internally.
• Pay strong attention to detail.
• Manage projects. Create project plans and timelines.
• Think analytically and critically.
• Organize and track complex information.
• Exercise judgment within generally defined practices and policies in selecting methods and
• techniques for obtaining solutions.
• Has a sound knowledge of a variety of alternatives and their impact on the business.
• Apply business and regulatory ethical standards.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Additional Information

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, sexual orientation or any other protected status.