Kelly Services Regulatory Manager in Schaumburg, Illinois
Kelly Services is actively recruiting for a Regulatory Manager for a Direct Hire opportunity in Greater Chicago area, IL.
The Regulatory Manager leads/executes and monitors staff members to ensure the on-time filing of high-quality regulatory submissions, and to assemble, maintain, and control regulatory dossiers, Annual Reports, licenses/registrations, quality agreement and QMS regulatory requirements. S/he mentors and provides regulatory leadership and strategic guidance to team members. The Manager interacts with all levels in the organization, and across several functions, including Marketing, R&D, engineering, manufacturing and QA/QC. The manager interfaces with regulatory agencies, including the FDA, Health Canada and Latin America distributors or government agencies as appropriate, as it relates to submissions, regulatory compliance, post market surveillance, field action and other relevant topics. The Regulatory Manager is responsible for maintaining and improving Clients QMS, ensures regulatory compliance requirements are met, monitors regulatory notices/updates and changes in enforcement by the FDA, Health Canada and other global regulatory agencies where Client products are distributed as well as ensures any signals from post market surveillance which may affect the QMS state, effectiveness or comprehensiveness are identified, escalated, impact/risk assessed and action taken to ensure compliance to regulatory requirements.
In this position you will use your experience to:
Interact with FDA (and any other global agencies) for all products including Class I, II and III medical devices, exempt medical devices, OTC and ANDA drug products manufactured on site, by CMO’s (contract manufacturing organizations) on behalf of client, under private label or not:
Oversees the preparation and filing of high-quality submissions, reports, notifications, licensing/registration and follow-up inquiries to/from regulatory authorities
Ensures that all applications are filed/maintained in accordance with predetermined timelines including state/country licenses and site registrations.
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, analyzes and strategizes with client management and FDA (including applicable regulatory agencies) regarding deficiencies, citations, notifications or other issues
Prepares and monitors submission meetings, registrations and any regulatory updates with FDA, Health Canada and Latin America as required.
Supports any other agency/geography regulatory filings, notifications, licensing, registrations as required.
Participates, organizes, manages external inspections, audits as well as supports the execution of internal and supplier audits.
Maintains the site master product list, updating activity, regulatory classification, geographies (etc) as required to remain current for all products and materials client produces, distributes, owns or manages.
Must maintain his/her knowledge of current globally regulatory expectations, enforcements, and changes (new/revised) in requirements, standards, guidances and regulations, in particular from the FDA, Health Canada, Latin America countries and others as required.
Evaluate and facilitate product development activities, product changes, QMS changes, regulatory compliance:
Creates and evaluates regulatory impact of changes and proposals for product and process issues, compliance-related remediation, new regulatory requirements/expectations including notices, guidance documents, enforcement actions, citations, Warning Letters (etc), post market surveillance and industry trends.
Provides regulatory training and advice internally
Educates and trains management and other employees to familiarize them with regulatory requirements, FDA expectations/enforcements, global regulatory requirements and industry trends.
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.
Creates and maintains Annual Reports for drug products to ensure accuracy/completeness in the content filed, timeliness of filing and compliance to all regulatory requirements.
Ensures regulatory requirements of quality agreements (including supply, purchasing, licensing, distribution contracts) are met, monitored and maintains for all products and geographies.
Supports and monitors completion of APRs (Annual Product Reviews) including data analysis and collection.
Supports and monitors timely completion of complaint analysis, investigation, impact/risk assessment and reportability decisions including completion AE/SAE/MDR filings.
Lead the development, maintenance and process monitoring of Regulatory Affairs function to ensure Client’s continuing compliance with FDA and other regulatory authorities for all products and QMS activities.
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, metrics, process monitoring and procedures for RA and the QMS
Gathers industry insights (pharma and device) by actively participating in professional organizations, and by researching scientific and regulatory literature to keep current and emerging technical and regulatory requirements affecting client products, changes in enforcement or regulations, standards, guidance documents.
Escalating issues, gaps, and any potential impact/risk to client’s products in distribution, development, testing or manufacturing including CMO products.
Creating, managing and supporting risk assessments, compliance reviews, Health Hazard Evaluations (HHE), Post Market Surveillance and strategic regulatory advisement regarding any product issues/failures, potential patient/customer safety issues, complaint analysis and reportability decisions, field impact or field action, regulatory notices or enforcement.
Identifies compliance issues and communicates to the Director, Quality & RA and management.
Supports compliance and QMS activities and projects as assigned including completion of CAPAs, NCR, Deviations, Change Controls, Training, complaints (including FDA reporting/filing AE, SAE, MDR), impact assessments, remediation activities, gap assessments, and risk assessments.
Continually adapts and innovates processes to ensure best practices
Ensures that executive management is aware of team activities and progress with consistent regulatory communication, Management Review updates/metrics/monitoring and actively participates in various Review Boards (such as Risk Control Board, CAPA, Change Control etc) as well as complaint review, filings and reportability decisions.
Develops staff and conducts periodic performance reviews, including resource assessments, staff changes and allocation which ensures client’s QMS is maintained and compliant.
Supports Director of Quality, Regulatory in budget and managing expenses.
• Support periodic inspections performed by FDA and other regulatory authorities
The ideal candidate will possess:
A minimum of 5 years regulatory and compliance experience in medical device and drug regulated industry, including substantial handling, management of ANDAs or ANDA supplements, Annual Reports, and 510(k) applications, Complaints, and Post Market Surveillance.
Thorough understanding of the CFRs, FDA andICH guidelines, QSRs and cGxPs as they pertain to medical devices and drug products including regulatory intelligence gathering, regulatory impact assessments, risk management and change control.
Working knowledge of compliance requirements in Europe. Latin America, Asia and Canada.
Excellent writing and editing skills necessary for regulatory documentation using Word, Excel, PowerPoint, etc as well as verbal communication and presentation skills.
Knowledgeable in QMS requirements, CAPA, Change control, CGxP including Risk Management.
At least 5 years in a management position overseeing Regulatory Affairs and compliance requirements.
Regulatory Affairs Certification (RAC) preferred.
Quality Assurance experience preferred.
Demonstrated proficiency in the use of databases, spreadsheets, web-based applications, FDA filing platforms (such as e-submitter, MAUDE, MedWatch, FURLS and drug databases)
Excellent computer skills. Experience with MS Office applications.
Well-developed communication skills, written and verbal.
Projects professionalism and a courteous, cooperative demeanor and works collaboratively and cross-functionally to achieve goals, process monitor and resolve problems
Problem analysis and problem resolution skills including excellent application of risk management principles and critical thinking.
Management: the ability to organize and manage multiple priorities which meet compliance requirements and expectations, timeliness and thoroughness.
Ability to communicate, interact and work effectively with people from diverse backgrounds, as well as across all levels of the organization
Planning/Anticipation: an ability to think ahead and plan over a 3-6-12 month time span applying excellent project management skills, communication and progress reporting, course corrections and escalation.
Quality and compliance-oriented with attention to detail and pro-active/preventive approach to compliance.
Hands-on management, participates in all aspects of the job and leads by example
Comprehensive insurance coverage that includes Medical, Vision, Life and disability insurance plans along with enhanced Dental benefits.
Company Paid Life & AD&D and Optional Life Insurance
Flexible Spending and Health Savings Accounts
Pet, Legal and Identity Theft Insurance Plans
Employee Assistance Program
Wellness program including an onsite fitness center.
401K retirement plan with 5% employer match (Pretax and Roth options)
401k profit sharing contribution based on company performance
Paid holidays and generous paid time off.
Competitive annual bonus and sales incentive programs
On-site café featuring daily specials with dinner-to-go options.
Miles of beautifully maintained walking trails.
Numerous employee appreciation events throughout the year.
Professional development and training classes
Flexible schedule including work from home options
Employee discounts on oral care products
If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.
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About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
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