Title: Regulatory Manager
Position: Direct Hire
Location: Schaumburg, IL
The Regulatory Manager guides staff members to ensure the on-time filing of high-quality regulatory submissions, and to assemble, maintain, and control regulatory dossiers. S/he mentors and provides regulatory guidance to team members. The Manager interacts with all levels in the organization, and across several functions, particularly Marketing, R&D, engineering, manufacturing and QA/QC. S/he participates in discussions with management and provides strategic regulatory guidance. The manager interfaces with regulatory agencies, primarily the FDA, as it relates to submissions and other relevant topics.
In this position you will use your experience to:
- Interact with FDA for Class II and III medical devices and OTC and ANDA drug products:
- Oversees the preparation and filing of high-quality submissions to regulatory authorities
- Ensures that all applications are filed in accordance with predetermined timelines
- Provides expert regulatory strategy/guidance to staff and inter-disciplinary project teams
- Serves as Primary point of contact for FDA on U.S. submissions.
- Interacts and negotiates with FDA regarding strategy and resolution of deficiency issues
- Coordinates and attends pre-submission meetings with FDA
- Facilitate product development of Class II and III medical devices and OTC and Rx drug products:
- Provides regulatory training and advice internally
- Educates and trains top management and other employees to familiarize them with regulatory requirements.
- Provides Regulatory support to Product Development teams including R&D Scientists and Engineers for designing clinical protocols, packaging, labeling and promotional materials.
- Works with R&D Scientists and Engineers to plan, develop and execute new products, methods, technologies, and acceptance criteria
- Evaluates experimental data, interprets results, writes or critically reviews summary reports.
- Lead the development of Regulatory Affairs function to ensure Sunstar’s continuing compliance with FDA and other regulatory authorities
- Works with regulatory experts and colleagues in other regions (Asia, Europe, Latin America, Canada) to expand and maximize business opportunities outside of the U.S.
- Develops quality standards and procedures for RA
- Gathers industry insights (pharma and device) by actively participating in professional organizations, and by researching scientific and regulatory literature to keep abreast of current and emerging technical and regulatory requirements affecting SAI products.
- Identifies compliance issues and communicates same to the Director, Q & RA
- Leads compliance activities and projects as assigned.
- Continually adapts and innovates processes to ensure best practices
- Ensures that executive management is aware of team activities and progress
- Develops staff and conducts mid-year and annual reviews
- Prepares annual budget and manages expenses
- Support periodic inspections performed by FDA and other regulatory authorities
- Bachelor’s Degree required; Master’s Degree preferred
- A minimum of 5 years regulatory experience in medical device, including substantial handling of ANDAs or ANDA supplements, Annual Reports, and 510(k) applications.
- Thorough understanding of the CFR, FDA/ICH guidelines, QSRs and cGMPs as they pertain to medical devices and drug products.
- Working knowledge of compliance requirements in Europe and Canada.
- Excellent writing and editing skills necessary for regulatory documentation using Word, Excel, PowerPoint, etc.
- Regulatory Affairs Certification (RAC) beneficial
- Demonstrated proficiency in the use of databases, spreadsheets, and statistical software.
- Well-developed communication skills, written and verbal
- Projects professionalism and a courteous, cooperative demeanor
- Problem analysis and problem resolution skills
- Management: the ability to organize and manage multiple priorities.
- Ability to communicate, interact and work effectively with people from diverse backgrounds, as well as across all levels of the organization
- Planning: an ability to think ahead and plan over a 3-6 month time span
- Quality orientation and attention to detail